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The Purple Book database contains information on all FDA-licensed (approved) biological products regulated by
the Center for Drug Evaluation and Research (CDER), including licensed biosimilar and interchangeable
products,
and their reference products.
The Purple Book also contains information about all FDA-licensed allergenic, cellular and gene therapy,
hematologic, and vaccine products regulated by the Center for Biologics Evaluation and Research (CBER).
Enter a product's proprietary (brand) name or the nonproprietary (proper) name to find biological products.
As
you type, a list of potential results will begin to appear below the search box based on what you are
typing.
Click on a product from the auto-populated results list below to view the results page. The results page for
your selected product will include all biological products that share a core name (i.e., biosimilar,
interchangeable, reference, and related biological products).
(raxibacumab)
BLA Number
: 125349
351(a)
(penpulimab-kcqx)
BLA Number
: 761258
351(a)
(Insects (Whole Body), Mite Dermatophagoides farinae)
BLA Number
: 101834
351(a)
(Insects (Whole Body), Mite Dermatophagoides farinae)
BLA Number
: 101834
351(a)
(Insects (Whole Body), Mite Dermatophagoides farinae)
BLA Number
: 101834
351(a)
(Insects (Whole Body), Mite Dermatophagoides farinae)
BLA Number
: 101834
351(a)
(Insects (Whole Body), Mite Dermatophagoides farinae)
BLA Number
: 101834
351(a)
(Insects (Whole Body), Mite Dermatophagoides farinae)
BLA Number
: 101834
351(a)
(Insects (Whole Body), Mite Dermatophagoides farinae)
BLA Number
: 101834
351(a)
(Insects (Whole Body), Mite Dermatophagoides pteronyssinus)
BLA Number
: 101835
351(a)
(Insects (Whole Body), Mite Dermatophagoides pteronyssinus)
BLA Number
: 101835
351(a)
(Insects (Whole Body), Mite Dermatophagoides pteronyssinus)
BLA Number
: 101835
351(a)
(Insects (Whole Body), Mite Dermatophagoides pteronyssinus)
BLA Number
: 101835
351(a)
(Insects (Whole Body), Mite Dermatophagoides pteronyssinus)
BLA Number
: 101835
351(a)
(Insects (Whole Body), Mite Dermatophagoides pteronyssinus)
BLA Number
: 101835
351(a)
(Insects (Whole Body), Mite Dermatophagoides pteronyssinus)
BLA Number
: 101835
351(a)
(Pollens - Grasses, Bermuda Grass Cynodon dactylon)
BLA Number
: 101836
351(a)
(Pollens - Grasses, Bermuda Grass Cynodon dactylon)
BLA Number
: 101836
351(a)
(Pollens - Grasses, Bermuda Grass Cynodon dactylon)
BLA Number
: 101836
351(a)
(Pollens - Grasses, Bermuda Grass Cynodon dactylon)
BLA Number
: 101836
351(a)
(Pollens - Grasses, Bermuda Grass Cynodon dactylon)
BLA Number
: 101836
351(a)
(Pollens - Grasses, Bermuda Grass Cynodon dactylon)
BLA Number
: 101836
351(a)
(Pollens - Grasses, Bluegrass, Kentucky (June) Poa pratensis)
BLA Number
: 101837
351(a)
(Pollens - Grasses, Bluegrass, Kentucky (June) Poa pratensis)
BLA Number
: 101837
351(a)
(Pollens - Grasses, Bluegrass, Kentucky (June) Poa pratensis)
BLA Number
: 101837
351(a)
(Pollens - Grasses, Fescue, Meadow Festuca elatior)
BLA Number
: 101838
351(a)
(Pollens - Grasses, Fescue, Meadow Festuca elatior)
BLA Number
: 101838
351(a)
(Pollens - Grasses, Fescue, Meadow Festuca elatior)
BLA Number
: 101838
351(a)
(Pollens - Grasses, Fescue, Meadow Festuca elatior)
BLA Number
: 101838
351(a)
(Pollens - Grasses, Fescue, Meadow Festuca elatior)
BLA Number
: 101838
351(a)
(Pollens - Grasses, Fescue, Meadow Festuca elatior)
BLA Number
: 101838
351(a)
(Pollens - Grasses, Orchard Grass Dactylis glomerata)
BLA Number
: 101839
351(a)
(Pollens - Grasses, Orchard Grass Dactylis glomerata)
BLA Number
: 101839
351(a)
(Pollens - Grasses, Orchard Grass Dactylis glomerata)
BLA Number
: 101839
351(a)
(Pollens - Grasses, Orchard Grass Dactylis glomerata)
BLA Number
: 101839
351(a)
(Pollens - Grasses, Orchard Grass Dactylis glomerata)
BLA Number
: 101839
351(a)
(Pollens - Grasses, Orchard Grass Dactylis glomerata)
BLA Number
: 101839
351(a)
(Pollens - Grasses, Redtop Agrostis alba)
BLA Number
: 101840
351(a)
(Pollens - Grasses, Redtop Agrostis alba)
BLA Number
: 101840
351(a)
(Pollens - Grasses, Redtop Agrostis alba)
BLA Number
: 101840
351(a)
(Pollens - Grasses, Redtop Agrostis alba)
BLA Number
: 101840
351(a)
(Pollens - Grasses, Redtop Agrostis alba)
BLA Number
: 101840
351(a)
(Pollens - Grasses, Redtop Agrostis alba)
BLA Number
: 101840
351(a)
(Pollens - Grasses, Ryegrass, Perennial Lolium perenne)
BLA Number
: 101841
351(a)
(Pollens - Grasses, Ryegrass, Perennial Lolium perenne)
BLA Number
: 101841
351(a)
(Pollens - Grasses, Ryegrass, Perennial Lolium perenne)
BLA Number
: 101841
351(a)
(Pollens - Grasses, Ryegrass, Perennial Lolium perenne)
BLA Number
: 101841
351(a)
(Pollens - Grasses, Ryegrass, Perennial Lolium perenne)
BLA Number
: 101841
351(a)
(Pollens - Grasses, Ryegrass, Perennial Lolium perenne)
BLA Number
: 101841
351(a)
(Pollens - Grasses, Sweet Vernal Grass Anthoxanthum odoratum)
BLA Number
: 101842
351(a)
(Pollens - Grasses, Sweet Vernal Grass Anthoxanthum odoratum)
BLA Number
: 101842
351(a)
(Pollens - Grasses, Sweet Vernal Grass Anthoxanthum odoratum)
BLA Number
: 101842
351(a)
(Pollens - Grasses, Sweet Vernal Grass Anthoxanthum odoratum)
BLA Number
: 101842
351(a)
(Pollens - Grasses, Sweet Vernal Grass Anthoxanthum odoratum)
BLA Number
: 101842
351(a)
(Pollens - Grasses, Sweet Vernal Grass Anthoxanthum odoratum)
BLA Number
: 101842
351(a)
(Pollens - Grasses, Timothy Phleum pratense)
BLA Number
: 101843
351(a)
(Pollens - Grasses, Timothy Phleum pratense)
BLA Number
: 101843
351(a)
(Pollens - Grasses, Timothy Phleum pratense)
BLA Number
: 101843
351(a)
(Pollens - Grasses, Timothy Phleum pratense)
BLA Number
: 101843
351(a)
(Pollens - Grasses, Timothy Phleum pratense)
BLA Number
: 101843
351(a)
(Pollens - Grasses, Timothy Phleum pratense)
BLA Number
: 101843
351(a)
(Pollens - Weeds and Garden Plants, Ragweed, Short Ambrosia artemisiifolia)
BLA Number
: 101844
351(a)
(Pollens - Weeds and Garden Plants, Ragweed, Short Ambrosia artemisiifolia)
BLA Number
: 101844
351(a)
(Pollens - Weeds and Garden Plants, Ragweed, Short Ambrosia artemisiifolia)
BLA Number
: 101844
351(a)
(Pollens - Weeds and Garden Plants, Ragweed, Short Ambrosia elatior)
BLA Number
: 101845
351(a)
(Pollens - Weeds and Garden Plants, Ragweed, Short Ambrosia elatior)
BLA Number
: 101845
351(a)
(Pollens - Weeds and Garden Plants, Ragweed, Short Ambrosia elatior)
BLA Number
: 101845
351(a)
(Pollens - Weeds and Garden Plants, Ragweed, Short Ambrosia elatior)
BLA Number
: 101845
351(a)
(Pollens - Weeds and Garden Plants, Ragweed, Short Ambrosia elatior)
BLA Number
: 101845
351(a)
(Pollens - Weeds and Garden Plants, Ragweed, Short Ambrosia elatior)
BLA Number
: 101845
351(a)
(Albumin (Human))
BLA Number
: 101993
351(a)
(Insects (Whole Body), Mite Dermatophagoides farinae)
BLA Number
: 102212
351(a)
(Insects (Whole Body), Mite Dermatophagoides farinae)
BLA Number
: 102212
351(a)
(Insects (Whole Body), Mite Dermatophagoides farinae)
BLA Number
: 102212
351(a)
(Insects (Whole Body), Mite Dermatophagoides farinae)
BLA Number
: 102212
351(a)
(Insects (Whole Body), Mite Dermatophagoides farinae)
BLA Number
: 102212
351(a)
(Insects (Whole Body), Mite Dermatophagoides farinae)
BLA Number
: 102212
351(a)
(Insects (Whole Body), Mite Dermatophagoides farinae)
BLA Number
: 102212
351(a)
(Insects (Whole Body), Mite Dermatophagoides farinae)
BLA Number
: 102212
351(a)
(Insects (Whole Body), Mite Dermatophagoides pteronyssinus)
BLA Number
: 102213
351(a)
(Insects (Whole Body), Mite Dermatophagoides pteronyssinus)
BLA Number
: 102213
351(a)
(Insects (Whole Body), Mite Dermatophagoides pteronyssinus)
BLA Number
: 102213
351(a)
(Insects (Whole Body), Mite Dermatophagoides pteronyssinus)
BLA Number
: 102213
351(a)
(Insects (Whole Body), Mite Dermatophagoides pteronyssinus)
BLA Number
: 102213
351(a)
(Insects (Whole Body), Mite Dermatophagoides pteronyssinus)
BLA Number
: 102213
351(a)
(Insects (Whole Body), Mite Dermatophagoides pteronyssinus)
BLA Number
: 102213
351(a)
(Insects (Whole Body), Mite Dermatophagoides pteronyssinus)
BLA Number
: 102213
351(a)
(Pollens - Grasses, Bermuda Grass Cynodon dactylon)
BLA Number
: 102214
351(a)
(Pollens - Grasses, Bermuda Grass Cynodon dactylon)
BLA Number
: 102214
351(a)
(Pollens - Grasses, Bermuda Grass Cynodon dactylon)
BLA Number
: 102214
351(a)
(Pollens - Grasses, Bermuda Grass Cynodon dactylon)
BLA Number
: 102214
351(a)
(Pollens - Grasses, Bluegrass, Kentucky (June) Poa pratensis)
BLA Number
: 102215
351(a)
(Pollens - Grasses, Bluegrass, Kentucky (June) Poa pratensis)
BLA Number
: 102215
351(a)
(Pollens - Grasses, Bluegrass, Kentucky (June) Poa pratensis)
BLA Number
: 102215
351(a)
(Pollens - Grasses, Bluegrass, Kentucky (June) Poa pratensis)
BLA Number
: 102215
351(a)
(Pollens - Grasses, Bluegrass, Kentucky (June) Poa pratensis)
BLA Number
: 102215
351(a)
(Pollens - Grasses, Bluegrass, Kentucky (June) Poa pratensis)
BLA Number
: 102215
351(a)
(Pollens - Grasses, Bluegrass, Kentucky (June) Poa pratensis)
BLA Number
: 102215
351(a)
(Pollens - Grasses, Bluegrass, Kentucky (June) Poa pratensis)
BLA Number
: 102215
351(a)
(Pollens - Grasses, Fescue, Meadow Festuca elatior)
BLA Number
: 102216
351(a)
(Pollens - Grasses, Fescue, Meadow Festuca elatior)
BLA Number
: 102216
351(a)
(Pollens - Grasses, Fescue, Meadow Festuca elatior)
BLA Number
: 102216
351(a)
(Pollens - Grasses, Fescue, Meadow Festuca elatior)
BLA Number
: 102216
351(a)
(Pollens - Grasses, Fescue, Meadow Festuca elatior)
BLA Number
: 102216
351(a)
(Pollens - Grasses, Fescue, Meadow Festuca elatior)
BLA Number
: 102216
351(a)
(Pollens - Grasses, Fescue, Meadow Festuca elatior)
BLA Number
: 102216
351(a)
(Pollens - Grasses, Fescue, Meadow Festuca elatior)
BLA Number
: 102216
351(a)
(Pollens - Grasses, Orchard Grass Dactylis glomerata)
BLA Number
: 102217
351(a)
(Pollens - Grasses, Orchard Grass Dactylis glomerata)
BLA Number
: 102217
351(a)
(Pollens - Grasses, Orchard Grass Dactylis glomerata)
BLA Number
: 102217
351(a)
(Pollens - Grasses, Orchard Grass Dactylis glomerata)
BLA Number
: 102217
351(a)
(Pollens - Grasses, Orchard Grass Dactylis glomerata)
BLA Number
: 102217
351(a)
(Pollens - Grasses, Orchard Grass Dactylis glomerata)
BLA Number
: 102217
351(a)
(Pollens - Grasses, Orchard Grass Dactylis glomerata)
BLA Number
: 102217
351(a)
(Pollens - Grasses, Orchard Grass Dactylis glomerata)
BLA Number
: 102217
351(a)
(Pollens - Grasses, Redtop Agrostis alba)
BLA Number
: 102218
351(a)
(Pollens - Grasses, Redtop Agrostis alba)
BLA Number
: 102218
351(a)
(Pollens - Grasses, Redtop Agrostis alba)
BLA Number
: 102218
351(a)
(Pollens - Grasses, Redtop Agrostis alba)
BLA Number
: 102218
351(a)
(Pollens - Grasses, Redtop Agrostis alba)
BLA Number
: 102218
351(a)
(Pollens - Grasses, Redtop Agrostis alba)
BLA Number
: 102218
351(a)
(Pollens - Grasses, Redtop Agrostis alba)
BLA Number
: 102218
351(a)
(Pollens - Grasses, Redtop Agrostis alba)
BLA Number
: 102218
351(a)
(Pollens - Grasses, Ryegrass, Perennial Lolium perenne)
BLA Number
: 102219
351(a)
(Pollens - Grasses, Ryegrass, Perennial Lolium perenne)
BLA Number
: 102219
351(a)
(Pollens - Grasses, Ryegrass, Perennial Lolium perenne)
BLA Number
: 102219
351(a)
(Pollens - Grasses, Ryegrass, Perennial Lolium perenne)
BLA Number
: 102219
351(a)
(Pollens - Grasses, Ryegrass, Perennial Lolium perenne)
BLA Number
: 102219
351(a)
(Pollens - Grasses, Ryegrass, Perennial Lolium perenne)
BLA Number
: 102219
351(a)
(Pollens - Grasses, Ryegrass, Perennial Lolium perenne)
BLA Number
: 102219
351(a)
(Pollens - Grasses, Ryegrass, Perennial Lolium perenne)
BLA Number
: 102219
351(a)
(Pollens - Grasses, Sweet Vernal Grass Anthoxanthum odoratum)
BLA Number
: 102220
351(a)
(Pollens - Grasses, Sweet Vernal Grass Anthoxanthum odoratum)
BLA Number
: 102220
351(a)
(Pollens - Grasses, Sweet Vernal Grass Anthoxanthum odoratum)
BLA Number
: 102220
351(a)
(Pollens - Grasses, Sweet Vernal Grass Anthoxanthum odoratum)
BLA Number
: 102220
351(a)
(Pollens - Grasses, Sweet Vernal Grass Anthoxanthum odoratum)
BLA Number
: 102220
351(a)
(Pollens - Grasses, Sweet Vernal Grass Anthoxanthum odoratum)
BLA Number
: 102220
351(a)
(Pollens - Grasses, Sweet Vernal Grass Anthoxanthum odoratum)
BLA Number
: 102220
351(a)
(Pollens - Grasses, Sweet Vernal Grass Anthoxanthum odoratum)
BLA Number
: 102220
351(a)
(Pollens - Grasses, Timothy Phleum pratense)
BLA Number
: 102221
351(a)
(Pollens - Grasses, Timothy Phleum pratense)
BLA Number
: 102221
351(a)
(Pollens - Grasses, Timothy Phleum pratense)
BLA Number
: 102221
351(a)
(Pollens - Grasses, Timothy Phleum pratense)
BLA Number
: 102221
351(a)
(Antivenin (Latrodectus mactans))
BLA Number
: 101062
351(a)
(Antivenin (Latrodectus mactans))
BLA Number
: 101062
351(a)
(Antivenin (Crotalidae) Polyvalent)
BLA Number
: 101098
351(a)
(Antivenin (Micrurus fulvius))
BLA Number
: 101099
351(a)
(Insects (Whole Body), Mite Dermatophagoides farinae)
BLA Number
: 101377
351(a)
(Insects (Whole Body), Mite Dermatophagoides farinae)
BLA Number
: 101377
351(a)
(Insects (Whole Body), Mite Dermatophagoides pteronyssinus)
BLA Number
: 101378
351(a)
(Insects (Whole Body), Mite Dermatophagoides pteronyssinus)
BLA Number
: 101378
351(a)
(Pollens - Grasses, Bermuda Grass Cynodon dactylon)
BLA Number
: 101379
351(a)
(Pollens - Grasses, Bermuda Grass Cynodon dactylon)
BLA Number
: 101379
351(a)
(Pollens - Grasses, Bluegrass, Kentucky (June) Poa pratensis)
BLA Number
: 101380
351(a)
(Pollens - Grasses, Bluegrass, Kentucky (June) Poa pratensis)
BLA Number
: 101380
351(a)
(Pollens - Grasses, Bluegrass, Kentucky (June) Poa pratensis)
BLA Number
: 101380
351(a)
(Pollens - Grasses, Bluegrass, Kentucky (June) Poa pratensis)
BLA Number
: 101380
351(a)
(Pollens - Grasses, Fescue, Meadow Festuca elatior)
BLA Number
: 101381
351(a)
(Pollens - Grasses, Fescue, Meadow Festuca elatior)
BLA Number
: 101381
351(a)
(Pollens - Grasses, Fescue, Meadow Festuca elatior)
BLA Number
: 101381
351(a)
(Pollens - Grasses, Fescue, Meadow Festuca elatior)
BLA Number
: 101381
351(a)
(Pollens - Grasses, Orchard Grass Dactylis glomerata)
BLA Number
: 101382
351(a)
(Pollens - Grasses, Orchard Grass Dactylis glomerata)
BLA Number
: 101382
351(a)
(Pollens - Grasses, Orchard Grass Dactylis glomerata)
BLA Number
: 101382
351(a)
(Pollens - Grasses, Orchard Grass Dactylis glomerata)
BLA Number
: 101382
351(a)
(Pollens - Grasses, Redtop Agrostis alba)
BLA Number
: 101383
351(a)
(Pollens - Grasses, Redtop Agrostis alba)
BLA Number
: 101383
351(a)
(Pollens - Grasses, Redtop Agrostis alba)
BLA Number
: 101383
351(a)
(Pollens - Grasses, Redtop Agrostis alba)
BLA Number
: 101383
351(a)
(Pollens - Grasses, Ryegrass, Perennial Lolium perenne)
BLA Number
: 101384
351(a)
(Pollens - Grasses, Ryegrass, Perennial Lolium perenne)
BLA Number
: 101384
351(a)
(Pollens - Grasses, Ryegrass, Perennial Lolium perenne)
BLA Number
: 101384
351(a)
(Pollens - Grasses, Ryegrass, Perennial Lolium perenne)
BLA Number
: 101384
351(a)
(Pollens - Grasses, Sweet Vernal Grass Anthoxanthum odoratum)
BLA Number
: 101385
351(a)
(Pollens - Grasses, Sweet Vernal Grass Anthoxanthum odoratum)
BLA Number
: 101385
351(a)
(Pollens - Grasses, Sweet Vernal Grass Anthoxanthum odoratum)
BLA Number
: 101385
351(a)
(Pollens - Grasses, Sweet Vernal Grass Anthoxanthum odoratum)
BLA Number
: 101385
351(a)
(Pollens - Grasses, Timothy Phleum pratense)
BLA Number
: 101386
351(a)
(Pollens - Grasses, Timothy Phleum pratense)
BLA Number
: 101386
351(a)
(Pollens - Grasses, Timothy Phleum pratense)
BLA Number
: 101386
351(a)
(Pollens - Grasses, Timothy Phleum pratense)
BLA Number
: 101386
351(a)
(Pollens - Weeds and Garden Plants, Ragweed, Short Ambrosia artemisiifolia)
BLA Number
: 101387
351(a)
(Pollens - Weeds and Garden Plants, Ragweed, Short Ambrosia artemisiifolia)
BLA Number
: 101387
351(a)
(Pollens - Weeds and Garden Plants, Ragweed, Short Ambrosia artemisiifolia)
BLA Number
: 101387
351(a)
(BCG Vaccine)
BLA Number
: 103050
351(a)
(Pollens - Grasses, Bermuda Grass Cynodon dactylon)
BLA Number
: 103051
351(a)
(Pollens - Grasses, Bermuda Grass Cynodon dactylon)
BLA Number
: 103051
351(a)
(Pollens - Grasses, Bluegrass, Kentucky (June) Poa pratensis)
BLA Number
: 103052
351(a)
(Pollens - Grasses, Bluegrass, Kentucky (June) Poa pratensis)
BLA Number
: 103052
351(a)
(Pollens - Grasses, Bluegrass, Kentucky (June) Poa pratensis)
BLA Number
: 103052
351(a)
(Pollens - Grasses, Bluegrass, Kentucky (June) Poa pratensis)
BLA Number
: 103052
351(a)
(Pollens - Grasses, Fescue, Meadow Festuca elatior)
BLA Number
: 103053
351(a)
(Pollens - Grasses, Fescue, Meadow Festuca elatior)
BLA Number
: 103053
351(a)
(Pollens - Grasses, Fescue, Meadow Festuca elatior)
BLA Number
: 103053
351(a)
(Pollens - Grasses, Fescue, Meadow Festuca elatior)
BLA Number
: 103053
351(a)
(Pollens - Grasses, Orchard Grass Dactylis glomerata)
BLA Number
: 103054
351(a)
(Pollens - Grasses, Orchard Grass Dactylis glomerata)
BLA Number
: 103054
351(a)
(Pollens - Grasses, Orchard Grass Dactylis glomerata)
BLA Number
: 103054
351(a)
(Pollens - Grasses, Orchard Grass Dactylis glomerata)
BLA Number
: 103054
351(a)
(Pollens - Grasses, Redtop Agrostis alba)
BLA Number
: 103055
351(a)
(Pollens - Grasses, Redtop Agrostis alba)
BLA Number
: 103055
351(a)
(Pollens - Grasses, Redtop Agrostis alba)
BLA Number
: 103055
351(a)
(Pollens - Grasses, Redtop Agrostis alba)
BLA Number
: 103055
351(a)
(Pollens - Grasses, Ryegrass, Perennial Lolium perenne)
BLA Number
: 103056
351(a)
(Pollens - Grasses, Ryegrass, Perennial Lolium perenne)
BLA Number
: 103056
351(a)
(Pollens - Grasses, Sweet Vernal Grass Anthoxanthum odoratum)
BLA Number
: 103057
351(a)
(Pollens - Grasses, Sweet Vernal Grass Anthoxanthum odoratum)
BLA Number
: 103057
351(a)
(Pollens - Grasses, Timothy Phleum pratense)
BLA Number
: 103058
351(a)
(Pollens - Grasses, Timothy Phleum pratense)
BLA Number
: 103058
351(a)
(Pollens - Weeds and Garden Plants, Ragweed, Short Ambrosia artemisiifolia)
BLA Number
: 103059
351(a)
(Pollens - Weeds and Garden Plants, Ragweed, Short Ambrosia artemisiifolia)
BLA Number
: 103059
351(a)
(Insects (Whole Body), Mite Dermatophagoides farinae)
BLA Number
: 103060
351(a)
(Insects (Whole Body), Mite Dermatophagoides farinae)
BLA Number
: 103060
351(a)
(Animal Allergens, Standardized Cat Pelt)
BLA Number
: 103061
351(a)
(Animal Allergens, Standardized Cat Pelt)
BLA Number
: 103061
351(a)
(Pollens - Weeds and Garden Plants, Ragweed, Short Ambrosia artemisiifolia)
BLA Number
: 103113
351(a)
(Pollens - Weeds and Garden Plants, Ragweed, Short Ambrosia artemisiifolia)
BLA Number
: 103113
351(a)
(Positive Skin Test Control-Histamine)
BLA Number
: 103317
351(a)
(Animal Allergens, Standardized Cat Hair)
BLA Number
: 103324
351(a)
(Animal Allergens, Standardized Cat Hair)
BLA Number
: 103324
351(a)
(Animal Allergens, Standardized Cat Hair)
BLA Number
: 103397
351(a)
(Animal Allergens, Standardized Cat Hair)
BLA Number
: 103397
351(a)
(Animal Allergens, Standardized Cat Hair)
BLA Number
: 103397
351(a)
(Animal Allergens, Standardized Cat Hair)
BLA Number
: 103397
351(a)
(Animal Allergens, Standardized Cat Hair)
BLA Number
: 103397
351(a)
(Animal Allergens, Standardized Cat Hair)
BLA Number
: 103397
351(a)
(Animal Allergens, Standardized Cat Hair)
BLA Number
: 103397
351(a)
(Animal Allergens, Standardized Cat Hair)
BLA Number
: 103473
351(a)
(Animal Allergens, Standardized Cat Hair)
BLA Number
: 103473
351(a)
(Plague Vaccine)
BLA Number
: 103569
351(a)
(Insects (Whole Body), Mite Dermatophagoides farinae)
BLA Number
: 103870
351(a)
(Insects (Whole Body), Mite Dermatophagoides farinae)
BLA Number
: 103870
351(a)
(Insects (Whole Body), Mite Dermatophagoides farinae)
BLA Number
: 103870
351(a)
(Insects (Whole Body), Mite Dermatophagoides farinae)
BLA Number
: 103870
351(a)
(Insects (Whole Body), Mite Dermatophagoides farinae)
BLA Number
: 103870
351(a)
(Insects (Whole Body), Mite Dermatophagoides pteronyssinus)
BLA Number
: 103871
351(a)
(Insects (Whole Body), Mite Dermatophagoides pteronyssinus)
BLA Number
: 103871
351(a)
(Insects (Whole Body), Mite Dermatophagoides pteronyssinus)
BLA Number
: 103871
351(a)
(Insects (Whole Body), Mite Dermatophagoides pteronyssinus)
BLA Number
: 103871
351(a)
(Insects (Whole Body), Mite Dermatophagoides pteronyssinus)
BLA Number
: 103871
351(a)
(Pollens - Grasses, Bermuda Grass Cynodon dactylon)
BLA Number
: 103872
351(a)
(Pollens - Grasses, Bermuda Grass Cynodon dactylon)
BLA Number
: 103872
351(a)
(Pollens - Grasses, Bermuda Grass Cynodon dactylon)
BLA Number
: 103872
351(a)
(Pollens - Grasses, Bermuda Grass Cynodon dactylon)
BLA Number
: 103872
351(a)
(Pollens - Grasses, Bluegrass, Kentucky (June) Poa pratensis)
BLA Number
: 103873
351(a)
(Pollens - Grasses, Bluegrass, Kentucky (June) Poa pratensis)
BLA Number
: 103873
351(a)
(Pollens - Grasses, Bluegrass, Kentucky (June) Poa pratensis)
BLA Number
: 103873
351(a)
(Pollens - Grasses, Bluegrass, Kentucky (June) Poa pratensis)
BLA Number
: 103873
351(a)
(Pollens - Grasses, Bluegrass, Kentucky (June) Poa pratensis)
BLA Number
: 103873
351(a)
(Pollens - Grasses, Bluegrass, Kentucky (June) Poa pratensis)
BLA Number
: 103873
351(a)
(Pollens - Grasses, Fescue, Meadow Festuca elatior)
BLA Number
: 103874
351(a)
(Pollens - Grasses, Fescue, Meadow Festuca elatior)
BLA Number
: 103874
351(a)
(Pollens - Grasses, Fescue, Meadow Festuca elatior)
BLA Number
: 103874
351(a)
(Pollens - Grasses, Fescue, Meadow Festuca elatior)
BLA Number
: 103874
351(a)
(Pollens - Grasses, Fescue, Meadow Festuca elatior)
BLA Number
: 103874
351(a)
(Pollens - Grasses, Fescue, Meadow Festuca elatior)
BLA Number
: 103874
351(a)
(Pollens - Grasses, Orchard Grass Dactylis glomerata)
BLA Number
: 103875
351(a)
(Pollens - Grasses, Orchard Grass Dactylis glomerata)
BLA Number
: 103875
351(a)
(Pollens - Grasses, Orchard Grass Dactylis glomerata)
BLA Number
: 103875
351(a)
(Pollens - Grasses, Orchard Grass Dactylis glomerata)
BLA Number
: 103875
351(a)
(Pollens - Grasses, Orchard Grass Dactylis glomerata)
BLA Number
: 103875
351(a)
(Pollens - Grasses, Orchard Grass Dactylis glomerata)
BLA Number
: 103875
351(a)
(Pollens - Grasses, Redtop Agrostis alba)
BLA Number
: 103876
351(a)
(Pollens - Grasses, Redtop Agrostis alba)
BLA Number
: 103876
351(a)
(Pollens - Grasses, Redtop Agrostis alba)
BLA Number
: 103876
351(a)
(Pollens - Grasses, Redtop Agrostis alba)
BLA Number
: 103876
351(a)
(Pollens - Grasses, Redtop Agrostis alba)
BLA Number
: 103876
351(a)
(Pollens - Grasses, Redtop Agrostis alba)
BLA Number
: 103876
351(a)
(Pollens - Grasses, Ryegrass, Perennial Lolium perenne)
BLA Number
: 103877
351(a)
(Pollens - Grasses, Ryegrass, Perennial Lolium perenne)
BLA Number
: 103877
351(a)
(Pollens - Grasses, Ryegrass, Perennial Lolium perenne)
BLA Number
: 103877
351(a)
(Pollens - Grasses, Ryegrass, Perennial Lolium perenne)
BLA Number
: 103877
351(a)
(Pollens - Grasses, Ryegrass, Perennial Lolium perenne)
BLA Number
: 103877
351(a)
(Pollens - Grasses, Ryegrass, Perennial Lolium perenne)
BLA Number
: 103877
351(a)
(Pollens - Grasses, Sweet Vernal Grass Anthoxanthum odoratum)
BLA Number
: 103878
351(a)
(Pollens - Grasses, Sweet Vernal Grass Anthoxanthum odoratum)
BLA Number
: 103878
351(a)
(Pollens - Grasses, Sweet Vernal Grass Anthoxanthum odoratum)
BLA Number
: 103878
351(a)
(Pollens - Grasses, Sweet Vernal Grass Anthoxanthum odoratum)
BLA Number
: 103878
351(a)
(Pollens - Grasses, Sweet Vernal Grass Anthoxanthum odoratum)
BLA Number
: 103878
351(a)
(Pollens - Grasses, Sweet Vernal Grass Anthoxanthum odoratum)
BLA Number
: 103878
351(a)
(Pollens - Grasses, Timothy Phleum pratense)
BLA Number
: 103879
351(a)
(Pollens - Grasses, Timothy Phleum pratense)
BLA Number
: 103879
351(a)
(Pollens - Grasses, Timothy Phleum pratense)
BLA Number
: 103879
351(a)
(Pollens - Grasses, Timothy Phleum pratense)
BLA Number
: 103879
351(a)
(Pollens - Grasses, Timothy Phleum pratense)
BLA Number
: 103879
351(a)
(Pollens - Grasses, Timothy Phleum pratense)
BLA Number
: 103879
351(a)
(Pollens - Weeds and Garden Plants, Ragweed, Short Ambrosia artemisiifolia)
BLA Number
: 103880
351(a)
(Pollens - Weeds and Garden Plants, Ragweed, Short Ambrosia artemisiifolia)
BLA Number
: 103880
351(a)
(Pollens - Weeds and Garden Plants, Ragweed, Short Ambrosia artemisiifolia)
BLA Number
: 103880
351(a)
(Venoms, Honey Bee Venom)
BLA Number
: 103882
351(a)
(Venoms, Honey Bee Venom)
BLA Number
: 103882
351(a)
(Venoms, Honey Bee Venom)
BLA Number
: 103882
351(a)
(Venoms, Honey Bee Venom)
BLA Number
: 103882
351(a)
(Venoms, Mixed Vespid Venom Protein)
BLA Number
: 103883
351(a)
(Venoms, Mixed Vespid Venom Protein)
BLA Number
: 103883
351(a)
(Venoms, Wasp Venom Protein)
BLA Number
: 103884
351(a)
(Venoms, Wasp Venom Protein)
BLA Number
: 103884
351(a)
(Venoms, Wasp Venom Protein)
BLA Number
: 103884
351(a)
(Venoms, Wasp Venom Protein)
BLA Number
: 103884
351(a)
(Venoms, White Faced Hornet Venom Protein)
BLA Number
: 103885
351(a)
(Venoms, White Faced Hornet Venom Protein)
BLA Number
: 103885
351(a)
(Venoms, White Faced Hornet Venom Protein)
BLA Number
: 103885
351(a)
(Venoms, White Faced Hornet Venom Protein)
BLA Number
: 103885
351(a)
(Venoms, Yellow Hornet Venom Protein)
BLA Number
: 103886
351(a)
(Venoms, Yellow Hornet Venom Protein)
BLA Number
: 103886
351(a)
(Venoms, Yellow Hornet Venom Protein)
BLA Number
: 103886
351(a)
(Venoms, Yellow Hornet Venom Protein)
BLA Number
: 103886
351(a)
(Venoms, Yellow Jacket Venom Protein)
BLA Number
: 103887
351(a)
(Venoms, Yellow Jacket Venom Protein)
BLA Number
: 103887
351(a)
(Venoms, Yellow Jacket Venom Protein)
BLA Number
: 103887
351(a)
(Venoms, Yellow Jacket Venom Protein)
BLA Number
: 103887
351(a)
(Animal Allergens, Standardized Cat Hair)
BLA Number
: 103889
351(a)
(Animal Allergens, Standardized Cat Hair)
BLA Number
: 103889
351(a)
(Animal Allergens, Standardized Cat Hair)
BLA Number
: 103889
351(a)
(Animal Allergens, Standardized Cat Pelt)
BLA Number
: 103890
351(a)
(Animal Allergens, Standardized Cat Pelt)
BLA Number
: 103890
351(a)
(Animal Allergens, Standardized Cat Pelt)
BLA Number
: 103890
351(a)
(Positive Skin Test Control-Histamine)
BLA Number
: 103891
351(a)
(Insects (Whole Body), Mite Dermatophagoides pteronyssinus)
BLA Number
: 103752
351(a)
(Insects (Whole Body), Mite Dermatophagoides pteronyssinus)
BLA Number
: 103752
351(a)
(Animal Allergens, Standardized Cat Hair)
BLA Number
: 103810
351(a)
(Animal Allergens, Standardized Cat Hair)
BLA Number
: 103810
351(a)
(Tetanus Toxoid Adsorbed)
BLA Number
: 103913
351(a)
(Diphtheria & Tetanus Toxoids Adsorbed)
BLA Number
: 103919
351(a)
(Tetanus and Diphtheria Toxoids Adsorbed)
BLA Number
: 103921
351(a)
(Tetanus and Diphtheria Toxoids Adsorbed)
BLA Number
: 103921
351(a)
(Botulism Antitoxin Bivalent (Equine) Types A and B.)
BLA Number
: 103937
351(a)
(Diphtheria & Tetanus Toxoids Adsorbed)
BLA Number
: 103944
351(a)
(Albumin (Human))
BLA Number
: 125154
351(a)
(Albumin (Human))
BLA Number
: 125154
351(a)
(Albumin (Human))
BLA Number
: 125154
351(a)
(Albumin (Human))
BLA Number
: 125154
351(a)
(Albumin (Human))
BLA Number
: 125154
351(a)
(Albumin (Human))
BLA Number
: 125154
351(a)
(Albumin (Human))
BLA Number
: 125154
351(a)
(Influenza Virus Vaccine, H5N1)
BLA Number
: 125244
351(a)
(Adenovirus Type 4 and Type 7 Vaccine, Live, Oral)
BLA Number
: 125296
351(a)
(HPC, Cord Blood)
BLA Number
: 125391
351(a)
(HPC, Cord Blood)
BLA Number
: 125585
351(a)
(Hematopoietic Progenitor Cells, Cord (HPC-C))
BLA Number
: 125657
351(a)
A.P.L. (chorionic gonadotropin)
BLA Number
: 017055
351(a)
A.P.L. (chorionic gonadotropin)
BLA Number
: 017055
351(a)
A.P.L. (chorionic gonadotropin)
BLA Number
: 017055
351(a)
Abecma (idecabtagene vicleucel)
BLA Number
: 125736
351(a)
Abecma (idecabtagene vicleucel)
BLA Number
: 125736
351(a)
Abrilada (adalimumab-afzb)
BLA Number
: 761118
351(k) Interchangeable
Abrilada (adalimumab-afzb)
BLA Number
: 761118
351(k) Interchangeable
Abrilada (adalimumab-afzb)
BLA Number
: 761118
351(k) Interchangeable
Abrilada (adalimumab-afzb)
BLA Number
: 761118
351(k) Interchangeable
Abrilada (adalimumab-afzb)
BLA Number
: 761118
351(k) Interchangeable
Abrysvo (Respiratory Syncytial Virus Vaccine)
BLA Number
: 125769
351(a)
Acam2000 (Smallpox (Vaccinia) Vaccine, Live)
BLA Number
: 125158
351(a)
Accretropin (somatropin)
BLA Number
: 021538
351(a)
Actemra (tocilizumab)
BLA Number
: 125276
351(a)
Actemra (tocilizumab)
BLA Number
: 125276
351(a)
Actemra (tocilizumab)
BLA Number
: 125276
351(a)
Actemra (tocilizumab)
BLA Number
: 125472
351(a)
Actemra (tocilizumab)
BLA Number
: 125472
351(a)
Acthib,Omnihib (Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate))
BLA Number
: 103935
351(a)
Acthrel (corticorelin ovine triflutate)
BLA Number
: 020162
351(a)
Actimmune (interferon gamma-1b)
BLA Number
: 103836
351(a)
Activase (alteplase)
BLA Number
: 103172
351(a)
Activase (alteplase)
BLA Number
: 103172
351(a)
Adacel (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed)
BLA Number
: 125111
351(a)
Adagen (pegademase bovine)
BLA Number
: 019818
351(a)
Adakveo (crizanlizumab-tmca)
BLA Number
: 761128
351(a)
Adbry (tralokinumab-ldrm)
BLA Number
: 761180
351(a)
Adbry (tralokinumab-ldrm)
BLA Number
: 761180
351(a)
Adcetris (brentuximab vedotin)
BLA Number
: 125388
351(a)
Adlyxin (lixisenatide)
BLA Number
: 208471
351(a)
Adlyxin (lixisenatide)
BLA Number
: 208471
351(a)
Admelog (insulin lispro)
BLA Number
: 209196
351(a)
Admelog (insulin lispro)
BLA Number
: 209196
351(a)
Admelog (insulin lispro)
BLA Number
: 209196
351(a)
Adstiladrin (nadofaragene firadenovec-vncg)
BLA Number
: 125700
351(a)
Aduhelm (aducanumab-avwa)
BLA Number
: 761178
351(a)
Aduhelm (aducanumab-avwa)
BLA Number
: 761178
351(a)
Advate (Antihemophilic Factor (Recombinant), Plasma/Albumin Free Method)
BLA Number
: 125063
351(a)
Advate (Antihemophilic Factor (Recombinant), Plasma/Albumin Free Method)
BLA Number
: 125063
351(a)
Advate (Antihemophilic Factor (Recombinant), Plasma/Albumin Free Method)
BLA Number
: 125063
351(a)
Advate (Antihemophilic Factor (Recombinant), Plasma/Albumin Free Method)
BLA Number
: 125063
351(a)
Advate (Antihemophilic Factor (Recombinant), Plasma/Albumin Free Method)
BLA Number
: 125063
351(a)
Advate (Antihemophilic Factor (Recombinant), Plasma/Albumin Free Method)
BLA Number
: 125063
351(a)
Advate (Antihemophilic Factor (Recombinant), Plasma/Albumin Free Method)
BLA Number
: 125063
351(a)
Adynovate (Antihemophilic Factor (Recombinant), PEGylated)
BLA Number
: 125566
351(a)
Adynovate (Antihemophilic Factor (Recombinant), PEGylated)
BLA Number
: 125566
351(a)
Adynovate (Antihemophilic Factor (Recombinant), PEGylated)
BLA Number
: 125566
351(a)
Adynovate (Antihemophilic Factor (Recombinant), PEGylated)
BLA Number
: 125566
351(a)
Adynovate (Antihemophilic Factor (Recombinant), PEGylated)
BLA Number
: 125566
351(a)
Adynovate (Antihemophilic Factor (Recombinant), PEGylated)
BLA Number
: 125566
351(a)
Adynovate (Antihemophilic Factor (Recombinant), PEGylated)
BLA Number
: 125566
351(a)
ADZYNMA (ADAMTS13, recombinant-krhn)
BLA Number
: 125795
351(a)
ADZYNMA (ADAMTS13, recombinant-krhn)
BLA Number
: 125795
351(a)
Afluria, Afluria Quadrivalent (Influenza Vaccine)
BLA Number
: 125254
351(a)
Afluria, Afluria Quadrivalent (Influenza Vaccine)
BLA Number
: 125254
351(a)
Afluria, Afluria Quadrivalent (Influenza Vaccine)
BLA Number
: 125254
351(a)
Afluria, Afluria Quadrivalent (Influenza Vaccine)
BLA Number
: 125254
351(a)
Afluria, Afluria Quadrivalent (Influenza Vaccine)
BLA Number
: 125254
351(a)
Afrezza (insulin human)
BLA Number
: 022472
351(a)
Afrezza (insulin human)
BLA Number
: 022472
351(a)
Afrezza (insulin human)
BLA Number
: 022472
351(a)
Afstyla (Antihemophilic Factor (Recombinant), Single Chain)
BLA Number
: 125591
351(a)
Afstyla (Antihemophilic Factor (Recombinant), Single Chain)
BLA Number
: 125591
351(a)
Afstyla (Antihemophilic Factor (Recombinant), Single Chain)
BLA Number
: 125591
351(a)
Afstyla (Antihemophilic Factor (Recombinant), Single Chain)
BLA Number
: 125591
351(a)
Afstyla (Antihemophilic Factor (Recombinant), Single Chain)
BLA Number
: 125591
351(a)
Afstyla (Antihemophilic Factor (Recombinant), Single Chain)
BLA Number
: 125591
351(a)
Afstyla (Antihemophilic Factor (Recombinant), Single Chain)
BLA Number
: 125591
351(a)
Agriflu (Influenza Virus Vaccine)
BLA Number
: 125297
351(a)
Ahzantive (aflibercept-mrbb)
BLA Number
: 761378
351(k) Biosimilar
Ahzantive (aflibercept-mrbb)
BLA Number
: 761378
351(k) Biosimilar
Aimovig (erenumab-aooe)
BLA Number
: 761077
351(a)
Aimovig (erenumab-aooe)
BLA Number
: 761077
351(a)
Aimovig (erenumab-aooe)
BLA Number
: 761077
351(a)
Aimovig (erenumab-aooe)
BLA Number
: 761077
351(a)
Ajovy (fremanezumab-vfrm)
BLA Number
: 761089
351(a)
Ajovy (fremanezumab-vfrm)
BLA Number
: 761089
351(a)
Albuked, Plasbumin-20, Plasbumin-25, Plasbumin-5 (Albumin (Human))
BLA Number
: 101138
351(a)
Albuked, Plasbumin-20, Plasbumin-25, Plasbumin-5 (Albumin (Human))
BLA Number
: 101138
351(a)
Albuked, Plasbumin-20, Plasbumin-25, Plasbumin-5 (Albumin (Human))
BLA Number
: 101138
351(a)
Albuked, Plasbumin-20, Plasbumin-25, Plasbumin-5 (Albumin (Human))
BLA Number
: 101138
351(a)
Albuked, Plasbumin-20, Plasbumin-25, Plasbumin-5 (Albumin (Human))
BLA Number
: 101138
351(a)
Albuked, Plasbumin-20, Plasbumin-25, Plasbumin-5 (Albumin (Human))
BLA Number
: 101138
351(a)
Albuked, Plasbumin-20, Plasbumin-25, Plasbumin-5 (Albumin (Human))
BLA Number
: 101138
351(a)
Albuked, Plasbumin-20, Plasbumin-25, Plasbumin-5 (Albumin (Human))
BLA Number
: 101138
351(a)
Albuminar, Albuminar-20, Albuminar-25, Albuminar-5 (Albumin (Human))
BLA Number
: 103955
351(a)
Albuminar, Albuminar-20, Albuminar-25, Albuminar-5 (Albumin (Human))
BLA Number
: 103955
351(a)
Albuminar, Albuminar-20, Albuminar-25, Albuminar-5 (Albumin (Human))
BLA Number
: 103955
351(a)
Albuminar, Albuminar-20, Albuminar-25, Albuminar-5 (Albumin (Human))
BLA Number
: 103955
351(a)
Albuminar, Albuminar-20, Albuminar-25, Albuminar-5 (Albumin (Human))
BLA Number
: 103955
351(a)
Albuminar, Albuminar-20, Albuminar-25, Albuminar-5 (Albumin (Human))
BLA Number
: 103955
351(a)
Albuminar, Albuminar-20, Albuminar-25, Albuminar-5 (Albumin (Human))
BLA Number
: 103955
351(a)
Albuminar, Albuminar-20, Albuminar-25, Albuminar-5 (Albumin (Human))
BLA Number
: 103955
351(a)
Albuminex (Albumin (Human)-kjda)
BLA Number
: 125644
351(a)
Albuminex (Albumin (Human)-kjda)
BLA Number
: 125644
351(a)
Albuminex (Albumin (Human)-kjda)
BLA Number
: 125644
351(a)
Albuminex (Albumin (Human)-kjda)
BLA Number
: 125644
351(a)
Alburx (Albumin (Human))
BLA Number
: 102366
351(a)
Alburx (Albumin (Human))
BLA Number
: 102366
351(a)
Alburx (Albumin (Human))
BLA Number
: 102366
351(a)
Alburx (Albumin (Human))
BLA Number
: 102366
351(a)
Albutein (Albumin (Human))
BLA Number
: 102478
351(a)
Albutein (Albumin (Human))
BLA Number
: 102478
351(a)
Albutein (Albumin (Human))
BLA Number
: 102478
351(a)
Albutein (Albumin (Human))
BLA Number
: 102478
351(a)
Albutein (Albumin (Human))
BLA Number
: 102478
351(a)
Albutein (Albumin (Human))
BLA Number
: 102478
351(a)
Albutein (Albumin (Human))
BLA Number
: 102478
351(a)
Albutein (Albumin (Human))
BLA Number
: 102478
351(a)
Albutein (Albumin (Human))
BLA Number
: 102478
351(a)
Aldurazyme (laronidase)
BLA Number
: 125058
351(a)
Alferon N Injection (interferon alfa-n3 (human leukocyte derived))
BLA Number
: 103158
351(a)
Alhemo (concizumab-mtci)
BLA Number
: 761315
351(a)
Alhemo (concizumab-mtci)
BLA Number
: 761315
351(a)
Alhemo (concizumab-mtci)
BLA Number
: 761315
351(a)
Allocord (HPC, Cord Blood)
BLA Number
: 125413
351(a)
Alphanate (Antihemophilic Factor/von Willebrand Factor Complex (Human))
BLA Number
: 102475
351(a)
Alphanate (Antihemophilic Factor/von Willebrand Factor Complex (Human))
BLA Number
: 102475
351(a)
Alphanate (Antihemophilic Factor/von Willebrand Factor Complex (Human))
BLA Number
: 102475
351(a)
Alphanate (Antihemophilic Factor/von Willebrand Factor Complex (Human))
BLA Number
: 102475
351(a)
Alphanate (Antihemophilic Factor/von Willebrand Factor Complex (Human))
BLA Number
: 102475
351(a)
Alphanine, Alphanine Hp, Alphanine Sd (Coagulation Factor IX (Human))
BLA Number
: 103249
351(a)
Alphanine, Alphanine Hp, Alphanine Sd (Coagulation Factor IX (Human))
BLA Number
: 103249
351(a)
Alphanine, Alphanine Hp, Alphanine Sd (Coagulation Factor IX (Human))
BLA Number
: 103249
351(a)
Alphanine, Alphanine Hp, Alphanine Sd (Coagulation Factor IX (Human))
BLA Number
: 103249
351(a)
Alprolix (Coagulation Factor IX (Recombinant), Fc Fusion Protein)
BLA Number
: 125444
351(a)
Alprolix (Coagulation Factor IX (Recombinant), Fc Fusion Protein)
BLA Number
: 125444
351(a)
Alprolix (Coagulation Factor IX (Recombinant), Fc Fusion Protein)
BLA Number
: 125444
351(a)
Alprolix (Coagulation Factor IX (Recombinant), Fc Fusion Protein)
BLA Number
: 125444
351(a)
Alprolix (Coagulation Factor IX (Recombinant), Fc Fusion Protein)
BLA Number
: 125444
351(a)
Alprolix (Coagulation Factor IX (Recombinant), Fc Fusion Protein)
BLA Number
: 125444
351(a)
ALTUVIIIO (antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl)
BLA Number
: 125771
351(a)
ALTUVIIIO (antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl)
BLA Number
: 125771
351(a)
ALTUVIIIO (antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl)
BLA Number
: 125771
351(a)
ALTUVIIIO (antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl)
BLA Number
: 125771
351(a)
ALTUVIIIO (antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl)
BLA Number
: 125771
351(a)
ALTUVIIIO (antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl)
BLA Number
: 125771
351(a)
ALTUVIIIO (antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl)
BLA Number
: 125771
351(a)
Alyglo (immune globulin intravenous, human-stwk)
BLA Number
: 125743
351(a)
Alymsys (bevacizumab-maly)
BLA Number
: 761231
351(k) Biosimilar
Alymsys (bevacizumab-maly)
BLA Number
: 761231
351(k) Biosimilar
Amevive (alefacept)
BLA Number
: 125036
351(a)
Amevive (alefacept)
BLA Number
: 125036
351(a)
Amjevita (adalimumab-atto)
BLA Number
: 761024
351(k) Interchangeable
Amjevita (adalimumab-atto)
BLA Number
: 761024
351(k) Interchangeable
Amjevita (adalimumab-atto)
BLA Number
: 761024
351(k) Interchangeable
Amjevita (adalimumab-atto)
BLA Number
: 761024
351(k) Interchangeable
Amjevita (adalimumab-atto)
BLA Number
: 761024
351(k) Interchangeable
Amjevita (adalimumab-atto)
BLA Number
: 761024
351(k) Interchangeable
Amjevita (adalimumab-atto)
BLA Number
: 761024
351(k) Interchangeable
Amjevita (adalimumab-atto)
BLA Number
: 761024
351(k) Interchangeable
Amjevita (adalimumab-atto)
BLA Number
: 761024
351(k) Interchangeable
Amphadase (hyaluronidase)
BLA Number
: 021665
351(a)
AMTAGVI (Lifileucel)
BLA Number
: 125773
351(a)
Anascorp (Centruroides (Scorpion) Immune F(ab')2 (Equine) Injection)
BLA Number
: 125335
351(a)
Anavip (Crotalidae Immune F(ab')2 (Equine))
BLA Number
: 125488
351(a)
Andembry (garadacimab-gxii)
BLA Number
: 761367
351(a)
Andembry (garadacimab-gxii)
BLA Number
: 761367
351(a)
Andexxa (Coagulation Factor Xa (Recombinant), Inactivated-zhzo)
BLA Number
: 125586
351(a)
Andexxa (Coagulation Factor Xa (Recombinant), Inactivated-zhzo)
BLA Number
: 125586
351(a)
Anktiva (nogapendekin alfa inbakicept-pmln)
BLA Number
: 761336
351(a)
Anthim (obiltoxaximab)
BLA Number
: 125509
351(a)
Anthrasil (Anthrax Immune Globulin Intravenous (Human))
BLA Number
: 125562
351(a)
Apidra (insulin glulisine)
BLA Number
: 021629
351(a)
Apidra (insulin glulisine)
BLA Number
: 021629
351(a)
Apidra (insulin glulisine)
BLA Number
: 021629
351(a)
Aplisol (Tuberculin, Purified Protein Derivative)
BLA Number
: 103782
351(a)
Aralast, Aralast Np (Alpha-1-Proteinase Inhibitor (Human))
BLA Number
: 125039
351(a)
Aralast, Aralast Np (Alpha-1-Proteinase Inhibitor (Human))
BLA Number
: 125039
351(a)
Aranesp (darbepoetin alpha)
BLA Number
: 103951
351(a)
Aranesp (darbepoetin alpha)
BLA Number
: 103951
351(a)
Aranesp (darbepoetin alpha)
BLA Number
: 103951
351(a)
Aranesp (darbepoetin alpha)
BLA Number
: 103951
351(a)
Aranesp (darbepoetin alpha)
BLA Number
: 103951
351(a)
Aranesp (darbepoetin alpha)
BLA Number
: 103951
351(a)
Aranesp (darbepoetin alpha)
BLA Number
: 103951
351(a)
Aranesp (darbepoetin alpha)
BLA Number
: 103951
351(a)
Aranesp (darbepoetin alpha)
BLA Number
: 103951
351(a)
Aranesp (darbepoetin alpha)
BLA Number
: 103951
351(a)
Aranesp (darbepoetin alpha)
BLA Number
: 103951
351(a)
Aranesp (darbepoetin alpha)
BLA Number
: 103951
351(a)
Aranesp (darbepoetin alpha)
BLA Number
: 103951
351(a)
Aranesp (darbepoetin alpha)
BLA Number
: 103951
351(a)
Aranesp (darbepoetin alpha)
BLA Number
: 103951
351(a)
Aranesp (darbepoetin alpha)
BLA Number
: 103951
351(a)
Aranesp (darbepoetin alpha)
BLA Number
: 103951
351(a)
Aranesp (darbepoetin alpha)
BLA Number
: 103951
351(a)
Aranesp (darbepoetin alpha)
BLA Number
: 103951
351(a)
Aranesp (darbepoetin alpha)
BLA Number
: 103951
351(a)
Aranesp (darbepoetin alpha)
BLA Number
: 103951
351(a)
Aranesp (darbepoetin alpha)
BLA Number
: 103951
351(a)
Aranesp (darbepoetin alpha)
BLA Number
: 103951
351(a)
Aranesp (darbepoetin alpha)
BLA Number
: 103951
351(a)
Aranesp (darbepoetin alpha)
BLA Number
: 103951
351(a)
Aranesp (darbepoetin alpha)
BLA Number
: 103951
351(a)
Aranesp (darbepoetin alpha)
BLA Number
: 103951
351(a)
Aranesp (darbepoetin alpha)
BLA Number
: 103951
351(a)
Aranesp (darbepoetin alpha)
BLA Number
: 103951
351(a)
Aranesp (darbepoetin alpha)
BLA Number
: 103951
351(a)
Aranesp (darbepoetin alpha)
BLA Number
: 103951
351(a)
Aranesp (darbepoetin alpha)
BLA Number
: 103951
351(a)
Aranesp (darbepoetin alpha)
BLA Number
: 103951
351(a)
Aranesp (darbepoetin alpha)
BLA Number
: 103951
351(a)
Aranesp (darbepoetin alpha)
BLA Number
: 103951
351(a)
Aranesp (darbepoetin alpha)
BLA Number
: 103951
351(a)
Aranesp (darbepoetin alpha)
BLA Number
: 103951
351(a)
Aranesp (darbepoetin alpha)
BLA Number
: 103951
351(a)
Aranesp (darbepoetin alpha)
BLA Number
: 103951
351(a)
Aranesp (darbepoetin alpha)
BLA Number
: 103951
351(a)
Aranesp (darbepoetin alpha)
BLA Number
: 103951
351(a)
Aranesp (darbepoetin alpha)
BLA Number
: 103951
351(a)
Aranesp (darbepoetin alpha)
BLA Number
: 103951
351(a)
Aranesp (darbepoetin alpha)
BLA Number
: 103951
351(a)
Aranesp (darbepoetin alpha)
BLA Number
: 103951
351(a)
Aranesp (darbepoetin alpha)
BLA Number
: 103951
351(a)
Aranesp (darbepoetin alpha)
BLA Number
: 103951
351(a)
Aranesp (darbepoetin alpha)
BLA Number
: 103951
351(a)
Aranesp (darbepoetin alpha)
BLA Number
: 103951
351(a)
Arcalyst (rilonacept)
BLA Number
: 125249
351(a)
Arepanrix (Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted)
BLA Number
: 125419
351(a)
Arexvy (Respiratory Syncytial Virus Vaccine, Adjuvanted)
BLA Number
: 125775
351(a)
Armlupeg (pegfilgrastim-unne)
BLA Number
: 761212
351(k) Biosimilar
Artiss (Fibrin Sealant (Human))
BLA Number
: 125266
351(a)
Artiss (Fibrin Sealant (Human))
BLA Number
: 125266
351(a)
Artiss (Fibrin Sealant (Human))
BLA Number
: 125266
351(a)
Artiss (Fibrin Sealant (Human))
BLA Number
: 125266
351(a)
Artiss (Fibrin Sealant (Human))
BLA Number
: 125266
351(a)
Artiss (Fibrin Sealant (Human))
BLA Number
: 125266
351(a)
Arzerra (ofatumumab)
BLA Number
: 125326
351(a)
Arzerra (ofatumumab)
BLA Number
: 125326
351(a)
Asceniv (Immune Globulin Intravenous, Human-slra)
BLA Number
: 125590
351(a)
Asparlas (calaspargase pegol-mknl)
BLA Number
: 761102
351(a)
Atgam (Lymphocyte Immune Globulin, Anti-thymocyte Globulin (Equine))
BLA Number
: 103676
351(a)
Atryn (Antithrombin (Recombinant))
BLA Number
: 125284
351(a)
Atryn (Antithrombin (Recombinant))
BLA Number
: 125284
351(a)
ATTENUVAX (Measles Virus Vaccine Live)
BLA Number
: 101068
351(a)
Aucatzyl (Obecabtagene autoleucel)
BLA Number
: 125813
351(a)
Audenz (Influenza A (H5N1) Monovalent Vaccine, Adjuvanted)
BLA Number
: 125692
351(a)
Aukelso (denosumab-kyqq)
BLA Number
: 761436
351(k) Interchangeable
Autoplex, Feiba Nf, Feiba Vh (Anti-Inhibitor Coagulant Complex)
BLA Number
: 101447
351(a)
Autoplex, Feiba Nf, Feiba Vh (Anti-Inhibitor Coagulant Complex)
BLA Number
: 101447
351(a)
Autoplex, Feiba Nf, Feiba Vh (Anti-Inhibitor Coagulant Complex)
BLA Number
: 101447
351(a)
Autoplex, Feiba Nf, Feiba Vh (Anti-Inhibitor Coagulant Complex)
BLA Number
: 101447
351(a)
Autoplex, Feiba Nf, Feiba Vh (Anti-Inhibitor Coagulant Complex)
BLA Number
: 101447
351(a)
avance nerve graft (acellular nerve allograft-arwx)
BLA Number
: 125816
351(a)
Avastin (bevacizumab)
BLA Number
: 125085
351(a)
Avastin (bevacizumab)
BLA Number
: 125085
351(a)
Avlayah (tividenofusp alfa-eknm)
BLA Number
: 761485
351(a)
Avonex (interferon beta-1a)
BLA Number
: 103628
351(a)
Avonex (interferon beta-1a)
BLA Number
: 103628
351(a)
Avonex (interferon beta-1a)
BLA Number
: 103628
351(a)
Avsola (infliximab-axxq)
BLA Number
: 761086
351(k) Biosimilar
Avtozma (tocilizumab-anoh)
BLA Number
: 761498
351(k) Interchangeable
Avtozma (tocilizumab-anoh)
BLA Number
: 761498
351(k) Biosimilar
Avtozma (tocilizumab-anoh)
BLA Number
: 761420
351(k) Interchangeable
Avtozma (tocilizumab-anoh)
BLA Number
: 761420
351(k) Interchangeable
Avtozma (tocilizumab-anoh)
BLA Number
: 761420
351(k) Interchangeable
Avzivi (bevacizumab-tnjn)
BLA Number
: 761198
351(k) Biosimilar
Avzivi (bevacizumab-tnjn)
BLA Number
: 761198
351(k) Biosimilar
Awiqli (insulin icodec-abae)
BLA Number
: 761326
351(a)
Awiqli (insulin icodec-abae)
BLA Number
: 761326
351(a)
Awiqli (insulin icodec-abae)
BLA Number
: 761326
351(a)
BabyBig (Botulism Immune Globulin Intravenous (Human))
BLA Number
: 125034
351(a)
Balfaxar (Prothrombin complex concentrate, human-lans)
BLA Number
: 125776
351(a)
Balfaxar (Prothrombin complex concentrate, human-lans)
BLA Number
: 125776
351(a)
Basaglar (insulin glargine)
BLA Number
: 205692
351(a)
Basaglar (insulin glargine)
BLA Number
: 205692
351(a)
Bat (Botulism Antitoxin Heptavalent (A, B, C, D, E, F, G) - (Equine))
BLA Number
: 125462
351(a)
Bavencio (avelumab)
BLA Number
: 761049
351(a)
Baygam, Gamastan S/D (Immune Globulin (Human))
BLA Number
: 101134
351(a)
Bayhep B, Hyperhep B S/D (Hepatitis B Immune Globulin (Human))
BLA Number
: 101146
351(a)
Bayhep B, Hyperhep B S/D (Hepatitis B Immune Globulin (Human))
BLA Number
: 101146
351(a)
Bayhep B, Hyperhep B S/D (Hepatitis B Immune Globulin (Human))
BLA Number
: 101146
351(a)
Bayhep B, Hyperhep B S/D (Hepatitis B Immune Globulin (Human))
BLA Number
: 101146
351(a)
Bayhep B, Hyperhep B S/D (Hepatitis B Immune Globulin (Human))
BLA Number
: 101146
351(a)
Bayrab, Hyperrab (Rabies Immune Globulin (Human))
BLA Number
: 101144
351(a)
Bayrab, Hyperrab (Rabies Immune Globulin (Human))
BLA Number
: 101144
351(a)
Bayrab,Hyperrab (Rabies Immune Globulin (Human))
BLA Number
: 101144
351(a)
Bayrho-D, Hyprho-D, Hyperrho S/D Full Dose, Hyperrho S/D Mini-Dose (Rho(D) Immune Globulin (Human))
BLA Number
: 101141
351(a)
Bayrho-D, Hyprho-D, Hyperrho S/D Full Dose, Hyperrho S/D Mini-Dose (Rho(D) Immune Globulin (Human))
BLA Number
: 101141
351(a)
Baytet, Hypertet (Tetanus Immune Globulin (Human))
BLA Number
: 101142
351(a)
Benefix (Coagulation Factor IX (Recombinant))
BLA Number
: 103677
351(a)
Benefix (Coagulation Factor IX (Recombinant))
BLA Number
: 103677
351(a)
Benefix (Coagulation Factor IX (Recombinant))
BLA Number
: 103677
351(a)
Benefix (Coagulation Factor IX (Recombinant))
BLA Number
: 103677
351(a)
Benefix (Coagulation Factor IX (Recombinant))
BLA Number
: 103677
351(a)
Benlysta (belimumab)
BLA Number
: 125370
351(a)
Benlysta (belimumab)
BLA Number
: 125370
351(a)
Benlysta (belimumab)
BLA Number
: 761043
351(a)
Benlysta (belimumab)
BLA Number
: 761043
351(a)
Beovu (brolucizumab-dbll)
BLA Number
: 761125
351(a)
Beovu (brolucizumab-dbll)
BLA Number
: 761125
351(a)
BEQVEZ (fidanacogene elaparvovec-dzkt)
BLA Number
: 125786
351(a)
Berinert (C1 Esterase Inhibitor (Human))
BLA Number
: 125287
351(a)
Besponsa (inotuzumab ozogamicin)
BLA Number
: 761040
351(a)
Besremi (ropeginterferon alfa-2b-njft)
BLA Number
: 761166
351(a)
Betaseron (interferon beta-1b)
BLA Number
: 103471
351(a)
Bexsero (Meningococcal Group B Vaccine)
BLA Number
: 125546
351(a)
Bexxar (tositumomab and iodine I-131 tositumomab)
BLA Number
: 125011
351(a)
Bexxar (tositumomab and iodine I-131 tositumomab)
BLA Number
: 125011
351(a)
Beyfortus (nirsevimab-alip)
BLA Number
: 761328
351(a)
Beyfortus (nirsevimab-alip)
BLA Number
: 761328
351(a)
Bildyos (denosumab-nxxp)
BLA Number
: 761444
351(k) Interchangeable
Bildyos (denosumab-nxxp)
BLA Number
: 761444
351(k) Interchangeable
Bilprevda (denosumab-nxxp)
BLA Number
: 761444
351(k) Interchangeable
Bimzelx (bimekizumab-bkzx)
BLA Number
: 761151
351(a)
Bimzelx (bimekizumab-bkzx)
BLA Number
: 761151
351(a)
Bimzelx (bimekizumab-bkzx)
BLA Number
: 761151
351(a)
Bimzelx (bimekizumab-bkzx)
BLA Number
: 761151
351(a)
Bioclate (Armour), Recombinate (Antihemophilic Factor (Recombinant))
BLA Number
: 103375
351(a)
Bioclate (Armour), Recombinate (Antihemophilic Factor (Recombinant))
BLA Number
: 103375
351(a)
Bioclate (Armour), Recombinate (Antihemophilic Factor (Recombinant))
BLA Number
: 103375
351(a)
Bioclate (Armour), Recombinate (Antihemophilic Factor (Recombinant))
BLA Number
: 103375
351(a)
Bioclate (Armour), Recombinate (Antihemophilic Factor (Recombinant))
BLA Number
: 103375
351(a)
Biorab (Rabies Vaccine Adsorbed)
BLA Number
: 103820
351(a)
Biothrax (Anthrax Vaccine Adsorbed)
BLA Number
: 103821
351(a)
Biothrax (Anthrax Vaccine Adsorbed)
BLA Number
: 103821
351(a)
Bivigam (Immune Globulin Intravenous (Human))
BLA Number
: 125389
351(a)
Bivigam (Immune Globulin Intravenous (Human))
BLA Number
: 125389
351(a)
Bizengri (zenocutuzumab-zbco)
BLA Number
: 761352
351(a)
Bkemv (eculizumab-aeeb)
BLA Number
: 761333
351(k) Interchangeable
Blenrep (belantamab mafodotin-blmf)
BLA Number
: 761158
351(a)
Blenrep (belantamab mafodotin-blmf)
BLA Number
: 761440
351(a)
Blincyto (blinatumomab)
BLA Number
: 125557
351(a)
Bomyntra (denosumab-bnht)
BLA Number
: 761398
351(k) Interchangeable
Bomyntra (denosumab-bnht)
BLA Number
: 761398
351(k) Interchangeable
Boncresa (denosumab-mobz)
BLA Number
: 761456
351(k) Interchangeable
Boostrix (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed)
BLA Number
: 125106
351(a)
Boostrix (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed)
BLA Number
: 125106
351(a)
Bosaya (denosumab-kyqq)
BLA Number
: 761436
351(k) Interchangeable
Botox (onabotulinumtoxinA)
BLA Number
: 103000
351(a)
Botox (onabotulinumtoxinA)
BLA Number
: 103000
351(a)
Botox (onabotulinumtoxinA)
BLA Number
: 103000
351(a)
Botox Cosmetic (onabotulinumtoxinA)
BLA Number
: 103000
351(a)
Botox Cosmetic (onabotulinumtoxinA)
BLA Number
: 103000
351(a)
Bravelle (urofollitropin)
BLA Number
: 021289
351(a)
Breyanzi (lisocabtagene maraleucel)
BLA Number
: 125714
351(a)
Brineura (cerliponase alfa)
BLA Number
: 761052
351(a)
Briumvi (ublituximab-xiiy)
BLA Number
: 761238
351(a)
Buminate, Flexbumin (Albumin (Human))
BLA Number
: 101452
351(a)
Buminate, Flexbumin (Albumin (Human))
BLA Number
: 101452
351(a)
Buminate, Flexbumin (Albumin (Human))
BLA Number
: 101452
351(a)
Buminate, Flexbumin (Albumin (Human))
BLA Number
: 101452
351(a)
Buminate, Flexbumin (Albumin (Human))
BLA Number
: 101452
351(a)
Byooviz (ranibizumab-nuna)
BLA Number
: 761202
351(k) Interchangeable
Cablivi (caplacizumab-yhdp)
BLA Number
: 761112
351(a)
Campath (alemtuzumab)
BLA Number
: 103948
351(a)
Campath (alemtuzumab)
BLA Number
: 103948
351(a)
Candin (Candida albicans Skin Test Antigen for Cellular Hypersensitivity)
BLA Number
: 103257
351(a)
CAPVAXIVE (Pneumococcal 21-valent Conjugate Vaccine)
BLA Number
: 125814
351(a)
Carimune, Carimune Nf, Panglobulin, Sandoglobulin (Immune Globulin Intravenous (Human))
BLA Number
: 102367
351(a)
Carimune, Carimune Nf, Panglobulin, Sandoglobulin (Immune Globulin Intravenous (Human))
BLA Number
: 102367
351(a)
Carimune, Carimune Nf, Panglobulin, Sandoglobulin (Immune Globulin Intravenous (Human))
BLA Number
: 102367
351(a)
Carticel Sm Service (Autologous Cultured Chondrocytes)
BLA Number
: 103661
351(a)
Carvykti (ciltacabtagene autoleucel)
BLA Number
: 125746
351(a)
Casgevy (Exagamglogene autotemcel)
BLA Number
: 125787
351(a)
Cathflo Activase (alteplase)
BLA Number
: 103172
351(a)
Ceprotin (Protein C Concentrate (Human))
BLA Number
: 125234
351(a)
Ceprotin (Protein C Concentrate (Human))
BLA Number
: 125234
351(a)
Cerezyme (imiglucerase)
BLA Number
: 020367
351(a)
Cerezyme (imiglucerase)
BLA Number
: 020367
351(a)
Cervarix (Human Papillomavirus Bivalent (Types 16 and 18) Vaccine, Recombinant)
BLA Number
: 125259
351(a)
Chorionic Gonadotropin (chorionic gonadotropin)
BLA Number
: 017067
351(a)
Chorionic Gonadotropin (chorionic gonadotropin)
BLA Number
: 017067
351(a)
Chorionic Gonadotropin (chorionic gonadotropin)
BLA Number
: 017067
351(a)
Chorionic Gonadotropin (chorionic gonadotropin)
BLA Number
: 017054
351(a)
Chorionic Gonadotropin (chorionic gonadotropin)
BLA Number
: 017054
351(a)
Chorionic Gonadotropin (chorionic gonadotropin)
BLA Number
: 017067
351(a)
Chromalbin (albumin chromated CR-51 serum)
BLA Number
: 017835
351(a)
Chromalbin (albumin chromated CR-51 serum)
BLA Number
: 017835
351(a)
Chromalbin (albumin chromated CR-51 serum)
BLA Number
: 017835
351(a)
Chymodiactin (chymopapain)
BLA Number
: 018663
351(a)
Chymodiactin (chymopapain)
BLA Number
: 018663
351(a)
Cimerli (ranibizumab-eqrn)
BLA Number
: 761165
351(k) Interchangeable
Cimerli (ranibizumab-eqrn)
BLA Number
: 761165
351(k) Interchangeable
Cimzia (certolizumab pegol)
BLA Number
: 125160
351(a)
Cimzia (certolizumab pegol)
BLA Number
: 125160
351(a)
Cinqair (reslizumab)
BLA Number
: 761033
351(a)
Cinryze (C1 Esterase Inhibitor (Human))
BLA Number
: 125267
351(a)
Clevecord (HPC, Cord Blood)
BLA Number
: 125594
351(a)
Cnj-016 (Vaccinia Immune Globulin Intravenous (Human))
BLA Number
: 125109
351(a)
Coagadex (Coagulation Factor X (Human))
BLA Number
: 125506
351(a)
Coagadex (Coagulation Factor X (Human))
BLA Number
: 125506
351(a)
Columvi (glofitamab-gxbm)
BLA Number
: 761309
351(a)
Columvi (glofitamab-gxbm)
BLA Number
: 761309
351(a)
Comirnaty (COVID-19 Vaccine, mRNA)
BLA Number
: 125742
351(a)
Comirnaty (COVID-19 Vaccine, mRNA)
BLA Number
: 125742
351(a)
Comirnaty (COVID-19 Vaccine, mRNA)
BLA Number
: 125742
351(a)
Comirnaty (COVID-19 Vaccine, mRNA)
BLA Number
: 125742
351(a)
Comirnaty (COVID-19 Vaccine, mRNA)
BLA Number
: 125742
351(a)
Comirnaty (COVID-19 Vaccine, mRNA)
BLA Number
: 125742
351(a)
COMVAX (Haemophilus b Conjugate (Meningococcal Protein Conjugate) and Hepatitis B (Recombinant) Vaccine)
BLA Number
: 103623
351(a)
Conexxence (denosumab-bnht)
BLA Number
: 761398
351(k) Interchangeable
Cordcyte (HPC, Cord Blood)
BLA Number
: 125432
351(a)
Corifact (Factor XIII Concentrate (Human))
BLA Number
: 125385
351(a)
Cosentyx (secukinumab)
BLA Number
: 125504
351(a)
Cosentyx (secukinumab)
BLA Number
: 125504
351(a)
Cosentyx (secukinumab)
BLA Number
: 125504
351(a)
Cosentyx (secukinumab)
BLA Number
: 125504
351(a)
Cosentyx (secukinumab)
BLA Number
: 125504
351(a)
Cosentyx (secukinumab)
BLA Number
: 125504
351(a)
Cosentyx (secukinumab)
BLA Number
: 761349
351(a)
Cotazym (pancrelipase)
BLA Number
: 020580
351(a)
Creon (pancrelipase)
BLA Number
: 020725
351(a)
Creon (pancrelipase)
BLA Number
: 020725
351(a)
Creon (pancrelipase)
BLA Number
: 020725
351(a)
Creon (pancrelipase)
BLA Number
: 020725
351(a)
Creon (pancrelipase)
BLA Number
: 020725
351(a)
Crofab (Crotalidae Polyvalent Immune Fab (Ovine))
BLA Number
: 103788
351(a)
Crosseal, Evicel (Fibrin Sealant (Human))
BLA Number
: 125010
351(a)
Crosseal, Evicel (Fibrin Sealant (Human))
BLA Number
: 125010
351(a)
Crosseal, Evicel (Fibrin Sealant (Human))
BLA Number
: 125010
351(a)
Crysvita (burosumab-twza)
BLA Number
: 761068
351(a)
Crysvita (burosumab-twza)
BLA Number
: 761068
351(a)
Crysvita (burosumab-twza)
BLA Number
: 761068
351(a)
Curosurf (poractant alfa)
BLA Number
: 020744
351(a)
Curosurf (poractant alfa)
BLA Number
: 020744
351(a)
Cutaquig (Immune Globulin Subcutaneous (Human)-hipp)
BLA Number
: 125668
351(a)
Cutaquig (Immune Globulin Subcutaneous (Human)-hipp)
BLA Number
: 125668
351(a)
Cutaquig (Immune Globulin Subcutaneous (Human)-hipp)
BLA Number
: 125668
351(a)
Cutaquig (Immune Globulin Subcutaneous (Human)-hipp)
BLA Number
: 125668
351(a)
Cutaquig (Immune Globulin Subcutaneous (Human)-hipp)
BLA Number
: 125668
351(a)
Cutaquig (Immune Globulin Subcutaneous (Human)-hipp)
BLA Number
: 125668
351(a)
Cuvitru (Immune Globulin Subcutaneous (Human), 20% Solution)
BLA Number
: 125596
351(a)
Cuvitru (Immune Globulin Subcutaneous (Human), 20% Solution)
BLA Number
: 125596
351(a)
Cuvitru (Immune Globulin Subcutaneous (Human), 20% Solution)
BLA Number
: 125596
351(a)
Cuvitru (Immune Globulin Subcutaneous (Human), 20% Solution)
BLA Number
: 125596
351(a)
Cuvitru (Immune Globulin Subcutaneous (Human), 20% Solution)
BLA Number
: 125596
351(a)
CYFENDUS (Anthrax Vaccine Adsorbed, Adjuvanted)
BLA Number
: 125761
351(a)
Cyltezo (adalimumab-adbm)
BLA Number
: 761058
351(k) Interchangeable
Cyltezo (adalimumab-adbm)
BLA Number
: 761058
351(k) Interchangeable
Cyltezo (adalimumab-adbm)
BLA Number
: 761058
351(k) Interchangeable
Cyltezo (adalimumab-adbm)
BLA Number
: 761058
351(k) Interchangeable
Cyltezo (adalimumab-adbm)
BLA Number
: 761058
351(k) Interchangeable
Cyltezo (adalimumab-adbm)
BLA Number
: 761058
351(k) Interchangeable
Cyramza (ramucirumab)
BLA Number
: 125477
351(a)
Cyramza (ramucirumab)
BLA Number
: 125477
351(a)
Cytogam (Cytomegalovirus Immune Globulin Intravenous (Human))
BLA Number
: 103189
351(a)
Danyelza (naxitamab-gqgk)
BLA Number
: 761171
351(a)
Daptacel (Diphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine Adsorbed)
BLA Number
: 103666
351(a)
Darzalex (daratumumab)
BLA Number
: 761036
351(a)
Darzalex (daratumumab)
BLA Number
: 761036
351(a)
Darzalex Faspro (daratumumab and hyaluronidase-fihj)
BLA Number
: 761145
351(a)
Datroway (datopotamab deruxtecan-dlnk)
BLA Number
: 761394
351(a)
Daxxify (daxibotulinumtoxinA-lanm)
BLA Number
: 761127
351(a)
Daxxify (daxibotulinumtoxinA-lanm)
BLA Number
: 761127
351(a)
Dengvaxia (Dengue Tetravalent Vaccine, Live)
BLA Number
: 125682
351(a)
Digibind (Digoxin Immune Fab (Ovine))
BLA Number
: 103141
351(a)
Digifab (Digoxin Immune Fab (Ovine))
BLA Number
: 103910
351(a)
Draximage MAA (kit for the preparation of technetium Tc-99m albumin aggregated)
BLA Number
: 017881
351(a)
Ducord (HPC, Cord Blood)
BLA Number
: 125407
351(a)
Dupixent (dupilumab)
BLA Number
: 761055
351(a)
Dupixent (dupilumab)
BLA Number
: 761055
351(a)
Dupixent (dupilumab)
BLA Number
: 761055
351(a)
Dupixent (dupilumab)
BLA Number
: 761055
351(a)
Dupixent (dupilumab)
BLA Number
: 761055
351(a)
Dupixent (dupilumab)
BLA Number
: 761055
351(a)
Dysport (abobotulinumtoxinA)
BLA Number
: 125274
351(a)
Dysport (abobotulinumtoxinA)
BLA Number
: 125274
351(a)
Ebanga (ansuvimab-zykl)
BLA Number
: 761172
351(a)
Ebglyss (lebrikizumab-lbkz)
BLA Number
: 761306
351(a)
Ebglyss (lebrikizumab-lbkz)
BLA Number
: 761306
351(a)
Egrifta (tesamorelin)
BLA Number
: 022505
351(a)
Egrifta SV (tesamorelin)
BLA Number
: 022505
351(a)
Egrifta WR (tesamorelin)
BLA Number
: 022505
351(a)
Elahere (mirvetuximab soravtansine-gynx)
BLA Number
: 761310
351(a)
Elaprase (idursulfase)
BLA Number
: 125151
351(a)
Elase-chloromycetin (fibrinolysin and desoxyribonuclease combined [bovine], with chloramphenicol)
BLA Number
: 050294
351(a)
Elelyso (taliglucerase alfa)
BLA Number
: 022458
351(a)
ELEVIDYS (delandistrogene moxeparvovec-rokl)
BLA Number
: 125781
351(a)
Elfabrio (pegunigalsidase alfa-iwxj)
BLA Number
: 761161
351(a)
Elfabrio (pegunigalsidase alfa-iwxj)
BLA Number
: 761161
351(a)
Elitek (rasburicase)
BLA Number
: 103946
351(a)
Elitek (rasburicase)
BLA Number
: 103946
351(a)
Eloctate (Antihemophilic Factor (Recombinant), Fc Fusion protein)
BLA Number
: 125487
351(a)
Eloctate (Antihemophilic Factor (Recombinant), Fc Fusion protein)
BLA Number
: 125487
351(a)
Eloctate (Antihemophilic Factor (Recombinant), Fc Fusion protein)
BLA Number
: 125487
351(a)
Eloctate (Antihemophilic Factor (Recombinant), Fc Fusion protein)
BLA Number
: 125487
351(a)
Eloctate (Antihemophilic Factor (Recombinant), Fc Fusion protein)
BLA Number
: 125487
351(a)
Eloctate (Antihemophilic Factor (Recombinant), Fc Fusion protein)
BLA Number
: 125487
351(a)
Eloctate (Antihemophilic Factor (Recombinant), Fc Fusion protein)
BLA Number
: 125487
351(a)
Eloctate (Antihemophilic Factor (Recombinant), Fc Fusion protein)
BLA Number
: 125487
351(a)
Eloctate (Antihemophilic Factor (Recombinant), Fc Fusion protein)
BLA Number
: 125487
351(a)
Eloctate (Antihemophilic Factor (Recombinant), Fc Fusion protein)
BLA Number
: 125487
351(a)
Elrexfio (elranatamab-bcmm)
BLA Number
: 761345
351(a)
Elrexfio (elranatamab-bcmm)
BLA Number
: 761345
351(a)
Elspar (asparaginase)
BLA Number
: 101063
351(a)
Elzonris (tagraxofusp-erzs)
BLA Number
: 761116
351(a)
Emgality (galcanezumab-gnlm)
BLA Number
: 761063
351(a)
Emgality (galcanezumab-gnlm)
BLA Number
: 761063
351(a)
Emgality (galcanezumab-gnlm)
BLA Number
: 761063
351(a)
Empliciti (elotuzumab)
BLA Number
: 761035
351(a)
Empliciti (elotuzumab)
BLA Number
: 761035
351(a)
Emrelis (telisotuzumab vedotin-tllv)
BLA Number
: 761384
351(a)
Emrelis (telisotuzumab vedotin-tllv)
BLA Number
: 761384
351(a)
Enbrel (etanercept)
BLA Number
: 103795
351(a)
Enbrel (etanercept)
BLA Number
: 103795
351(a)
Enbrel (etanercept)
BLA Number
: 103795
351(a)
Enbrel (etanercept)
BLA Number
: 103795
351(a)
Enbrel (etanercept)
BLA Number
: 103795
351(a)
Enbrel (etanercept)
BLA Number
: 103795
351(a)
Enbrel Mini (etanercept)
BLA Number
: 103795
351(a)
encelto (revakinagene taroretcel-lwey)
BLA Number
: 125798
351(a)
Enflonsia (clesrovimab-cfor)
BLA Number
: 761432
351(a)
Engerix-B (Hepatitis B Vaccine (Recombinant))
BLA Number
: 103239
351(a)
Engerix-B (Hepatitis B Vaccine (Recombinant))
BLA Number
: 103239
351(a)
Engerix-B (Hepatitis B Vaccine (Recombinant))
BLA Number
: 103239
351(a)
Engerix-B (Hepatitis B Vaccine (Recombinant))
BLA Number
: 103239
351(a)
Enhertu (fam-trastuzumab deruxtecan-nxki)
BLA Number
: 761139
351(a)
Enjaymo (sutimlimab-jome)
BLA Number
: 761164
351(a)
Enoby (denosumab-qbde)
BLA Number
: 761439
351(k) Interchangeable
Enspryng (satralizumab-mwge)
BLA Number
: 761149
351(a)
Entyvio (vedolizumab)
BLA Number
: 125476
351(a)
Entyvio (vedolizumab)
BLA Number
: 761133
351(a)
Entyvio Pen (vedolizumab)
BLA Number
: 761133
351(a)
Enzeevu (aflibercept-abzv)
BLA Number
: 761382
351(k) Biosimilar
Enzeevu (aflibercept-abzv)
BLA Number
: 761382
351(k) Biosimilar
Epkinly (epcoritamab-bysp)
BLA Number
: 761324
351(a)
Epkinly (epcoritamab-bysp)
BLA Number
: 761324
351(a)
Epogen/Procrit (epoetin alfa)
BLA Number
: 103234
351(a)
Epogen/Procrit (epoetin alfa)
BLA Number
: 103234
351(a)
Epogen/Procrit (epoetin alfa)
BLA Number
: 103234
351(a)
Epogen/Procrit (epoetin alfa)
BLA Number
: 103234
351(a)
Epogen/Procrit (epoetin alfa)
BLA Number
: 103234
351(a)
Epogen/Procrit (epoetin alfa)
BLA Number
: 103234
351(a)
Epysqli (eculizumab-aagh)
BLA Number
: 761340
351(k) Interchangeable
Erbitux (cetuximab)
BLA Number
: 125084
351(a)
Erbitux (cetuximab)
BLA Number
: 125084
351(a)
Erelzi (etanercept-szzs)
BLA Number
: 761042
351(k) Biosimilar
Erelzi (etanercept-szzs)
BLA Number
: 761042
351(k) Biosimilar
Erelzi (etanercept-szzs)
BLA Number
: 761042
351(k) Biosimilar
Erelzi Sensoready (etanercept-szzs)
BLA Number
: 761042
351(k) Biosimilar
Ervebo (Ebola Zaire Vaccine, Live)
BLA Number
: 125690
351(a)
Erwinaze (asparaginase Erwinia chrysanthemi)
BLA Number
: 125359
351(a)
Esperoct (Antihemophilic Factor (Recombinant), GlycoPEGylated-exei)
BLA Number
: 125671
351(a)
Esperoct (Antihemophilic Factor (Recombinant), GlycoPEGylated-exei)
BLA Number
: 125671
351(a)
Esperoct (Antihemophilic Factor (Recombinant), GlycoPEGylated-exei)
BLA Number
: 125671
351(a)
Esperoct (Antihemophilic Factor (Recombinant), GlycoPEGylated-exei)
BLA Number
: 125671
351(a)
Esperoct (Antihemophilic Factor (Recombinant), GlycoPEGylated-exei)
BLA Number
: 125671
351(a)
Eticovo (etanercept-ykro)
BLA Number
: 761066
351(k) Biosimilar
Eticovo (etanercept-ykro)
BLA Number
: 761066
351(k) Interchangeable
Eticovo (etanercept-ykro)
BLA Number
: 761066
351(k) Interchangeable
Evarrest (Fibrin Sealant Patch)
BLA Number
: 125392
351(a)
Evarrest (Fibrin Sealant Patch)
BLA Number
: 125392
351(a)
Evarrest (Fibrin Sealant Patch)
BLA Number
: 125392
351(a)
Evenity (romosozumab-aqqg)
BLA Number
: 761062
351(a)
Evithrom (Thrombin, Topical (Human))
BLA Number
: 125247
351(a)
Evithrom (Thrombin, Topical (Human))
BLA Number
: 125247
351(a)
Evithrom (Thrombin, Topical (Human))
BLA Number
: 125247
351(a)
Evithrom (Thrombin, Topical (Human))
BLA Number
: 125247
351(a)
Evkeeza (evinacumab-dgnb)
BLA Number
: 761181
351(a)
Evkeeza (evinacumab-dgnb)
BLA Number
: 761181
351(a)
Exdensur (depemokimab-ulaa)
BLA Number
: 761458
351(a)
Exdensur (depemokimab-ulaa)
BLA Number
: 761458
351(a)
Extavia (interferon beta-1b)
BLA Number
: 125290
351(a)
Eydenzelt (aflibercept-boav)
BLA Number
: 761377
351(k) Biosimilar
Eydenzelt (aflibercept-boav)
BLA Number
: 761377
351(k) Biosimilar
Eylea (aflibercept)
BLA Number
: 125387
351(a)
Eylea (aflibercept)
BLA Number
: 125387
351(a)
Eylea HD (aflibercept)
BLA Number
: 761355
351(a)
Fabrazyme (agalsidase beta)
BLA Number
: 103979
351(a)
Fabrazyme (agalsidase beta)
BLA Number
: 103979
351(a)
Fasenra (benralizumab)
BLA Number
: 761070
351(a)
Fasenra (benralizumab)
BLA Number
: 761070
351(a)
Fasenra (benralizumab)
BLA Number
: 761070
351(a)
FESILTY (fibrinogen, human–chmt)
BLA Number
: 125833
351(a)
Fiasp (insulin aspart)
BLA Number
: 208751
351(a)
Fiasp (insulin aspart)
BLA Number
: 208751
351(a)
Fiasp (insulin aspart)
BLA Number
: 208751
351(a)
Fiasp (insulin aspart)
BLA Number
: 208751
351(a)
Fibryga (Fibrinogen (Human))
BLA Number
: 125612
351(a)
Flebogamma 5%, Flebogamma 5% Dif (Immune Globulin Intravenous (Human))
BLA Number
: 125077
351(a)
Flebogamma 5%, Flebogamma 5% Dif (Immune Globulin Intravenous (Human))
BLA Number
: 125077
351(a)
Flebogamma 5%, Flebogamma 5% Dif (Immune Globulin Intravenous (Human))
BLA Number
: 125077
351(a)
Flebogamma 5%, Flebogamma 5% Dif (Immune Globulin Intravenous (Human))
BLA Number
: 125077
351(a)
Flebogamma 5%, Flebogamma 5% Dif (Immune Globulin Intravenous (Human))
BLA Number
: 125077
351(a)
Flebogamma 5%, Flebogamma 5% Dif (Immune Globulin Intravenous (Human))
BLA Number
: 125077
351(a)
Flebogamma 5%, Flebogamma 5% Dif (Immune Globulin Intravenous (Human))
BLA Number
: 125077
351(a)
Flebogamma 5%, Flebogamma 5% Dif (Immune Globulin Intravenous (Human))
BLA Number
: 125077
351(a)
Fluad (Influenza Vaccine, Adjuvanted)
BLA Number
: 125510
351(a)
Fluad,Fluad Quadrivalent (Influenza Vaccine, Adjuvanted)
BLA Number
: 125510
351(a)
Fluarix, Fluarix Quadrivalent (Influenza Vaccine)
BLA Number
: 125127
351(a)
Fluarix, Fluarix Quadrivalent (Influenza Vaccine)
BLA Number
: 125127
351(a)
Flublok (Influenza Vaccine)
BLA Number
: 125285
351(a)
Flublok (Influenza Vaccine)
BLA Number
: 125285
351(a)
Flublok (Influenza Vaccine)
BLA Number
: 125285
351(a)
Flucelvax, Flucelvax Quadrivalent (Influenza Vaccine)
BLA Number
: 125408
351(a)
Flucelvax, Flucelvax Quadrivalent (Influenza Vaccine)
BLA Number
: 125408
351(a)
Flucelvax, Flucelvax Quadrivalent (Influenza Vaccine)
BLA Number
: 125408
351(a)
Flucelvax, Flucelvax Quadrivalent (Influenza Vaccine)
BLA Number
: 125408
351(a)
Flucelvax, Flucelvax Quadrivalent (Influenza Vaccine)
BLA Number
: 125408
351(a)
Flulaval, Flulaval Quadrivalent (Influenza Vaccine)
BLA Number
: 125163
351(a)
Flulaval, Flulaval Quadrivalent (Influenza Vaccine)
BLA Number
: 125163
351(a)
Flulaval, Flulaval Quadrivalent (Influenza Vaccine)
BLA Number
: 125163
351(a)
Flulaval, Flulaval Quadrivalent (Influenza Vaccine)
BLA Number
: 125163
351(a)
Flulaval, Flulaval Quadrivalent (Influenza Vaccine)
BLA Number
: 125163
351(a)
Flumist, Flumist Quad (Influenza Vaccine Live, Intranasal)
BLA Number
: 125020
351(a)
Flumist, Flumist Quad (Influenza Vaccine Live, Intranasal)
BLA Number
: 125020
351(a)
Fluvirin (Influenza Virus Vaccine)
BLA Number
: 103837
351(a)
Fluzone, Fluzone Hd Quadrivalent, Fluzone High Dose, Fluzone Intradermal, Fluzone Quadrivalent (Influenza Virus Vaccine)
BLA Number
: 103914
351(a)
Fluzone, Fluzone Hd Quadrivalent, Fluzone High Dose, Fluzone Intradermal, Fluzone Quadrivalent (Influenza Virus Vaccine)
BLA Number
: 103914
351(a)
Fluzone, Fluzone Hd Quadrivalent, Fluzone High Dose, Fluzone Intradermal, Fluzone Quadrivalent (Influenza Virus Vaccine)
BLA Number
: 103914
351(a)
Fluzone, Fluzone Hd Quadrivalent, Fluzone High Dose, Fluzone Intradermal, Fluzone Quadrivalent (Influenza Virus Vaccine)
BLA Number
: 103914
351(a)
Fluzone, Fluzone Hd Quadrivalent, Fluzone High Dose, Fluzone Intradermal, Fluzone Quadrivalent (Influenza Virus Vaccine)
BLA Number
: 103914
351(a)
Fluzone, Fluzone Hd Quadrivalent, Fluzone High Dose, Fluzone Intradermal, Fluzone Quadrivalent (Influenza Virus Vaccine)
BLA Number
: 103914
351(a)
Fluzone, Fluzone Hd Quadrivalent, Fluzone High Dose, Fluzone Intradermal, Fluzone Quadrivalent (Influenza Virus Vaccine)
BLA Number
: 103914
351(a)
Fluzone, Fluzone Hd Quadrivalent, Fluzone High Dose, Fluzone Intradermal, Fluzone Quadrivalent (Influenza Virus Vaccine)
BLA Number
: 103914
351(a)
Fluzone, Fluzone Hd Quadrivalent, Fluzone High Dose, Fluzone Intradermal, Fluzone Quadrivalent (Influenza Virus Vaccine)
BLA Number
: 103914
351(a)
Fluzone, Fluzone Hd Quadrivalent, Fluzone High Dose, Fluzone Intradermal, Fluzone Quadrivalent (Influenza Virus Vaccine)
BLA Number
: 103914
351(a)
Follistim (follitropin beta)
BLA Number
: 020582
351(a)
Follistim (follitropin beta)
BLA Number
: 020582
351(a)
Follistim AQ (follitropin beta)
BLA Number
: 021273
351(a)
Follistim AQ (follitropin beta)
BLA Number
: 021273
351(a)
Follistim AQ Cartridge (follitropin beta)
BLA Number
: 021211
351(a)
Follistim AQ Cartridge (follitropin beta)
BLA Number
: 021211
351(a)
Follistim AQ Cartridge (follitropin beta)
BLA Number
: 021211
351(a)
Follistim AQ Cartridge (follitropin beta)
BLA Number
: 021211
351(a)
Fulphila (pegfilgrastim-jmdb)
BLA Number
: 761075
351(k) Biosimilar
Fylnetra (pegfilgrastim-pbbk)
BLA Number
: 761084
351(k) Biosimilar
Gamifant (emapalumab-lzsg)
BLA Number
: 761107
351(a)
Gamifant (emapalumab-lzsg)
BLA Number
: 761107
351(a)
Gamifant (emapalumab-lzsg)
BLA Number
: 761107
351(a)
Gamifant (emapalumab-lzsg)
BLA Number
: 761107
351(a)
Gamifant (emapalumab-lzsg)
BLA Number
: 761107
351(a)
Gamifant (emapalumab-lzsg)
BLA Number
: 761107
351(a)
Gamimune (Immune Globulin Intravenous (Human))
BLA Number
: 101147
351(a)
Gamimune (Immune Globulin Intravenous (Human))
BLA Number
: 101147
351(a)
Gammagard Liquid (Immune Globulin Infusion (Human))
BLA Number
: 125105
351(a)
Gammagard, Gammagard S/D, Iveegam (Immune Globulin Intravenous (Human))
BLA Number
: 103133
351(a)
Gammagard, Gammagard S/D, Iveegam (Immune Globulin Intravenous (Human))
BLA Number
: 103133
351(a)
Gammagard, Gammagard S/D, Iveegam (Immune Globulin Intravenous (Human))
BLA Number
: 103133
351(a)
Gammagard, Gammagard S/D, Iveegam (Immune Globulin Intravenous (Human))
BLA Number
: 103133
351(a)
Gammagard, Gammagard S/D, Iveegam (Immune Globulin Intravenous (Human))
BLA Number
: 103133
351(a)
Gammagard, Gammagard S/D, Iveegam (Immune Globulin Intravenous (Human))
BLA Number
: 103133
351(a)
Gammagard, Gammagard S/D, Iveegam (Immune Globulin Intravenous (Human))
BLA Number
: 103133
351(a)
Gammagard, Gammagard S/D, Iveegam (Immune Globulin Intravenous (Human))
BLA Number
: 103133
351(a)
Gammaked, Gamunex-C (Immune Globulin Injection (Human) 10% Caprylate/Chromatography Purified)
BLA Number
: 125046
351(a)
Gammaked, Gamunex-C (Immune Globulin Injection (Human) 10% Caprylate/Chromatography Purified)
BLA Number
: 125046
351(a)
Gammaked, Gamunex-C (Immune Globulin Injection (Human) 10% Caprylate/Chromatography Purified)
BLA Number
: 125046
351(a)
Gammaked, Gamunex-C (Immune Globulin Injection (Human) 10% Caprylate/Chromatography Purified)
BLA Number
: 125046
351(a)
Gammaked, Gamunex-C (Immune Globulin Injection (Human) 10% Caprylate/Chromatography Purified)
BLA Number
: 125046
351(a)
Gammaked, Gamunex-C (Immune Globulin Injection (Human) 10% Caprylate/Chromatography Purified)
BLA Number
: 125046
351(a)
Gammaked, Gamunex-C (Immune Globulin Injection (Human) 10% Caprylate/Chromatography Purified)
BLA Number
: 125046
351(a)
Gammaked, Gamunex-C (Immune Globulin Injection (Human) 10% Caprylate/Chromatography Purified)
BLA Number
: 125046
351(a)
Gammaked, Gamunex-C (Immune Globulin Injection (Human) 10% Caprylate/Chromatography Purified)
BLA Number
: 125046
351(a)
Gammaked, Gamunex-C (Immune Globulin Injection (Human) 10% Caprylate/Chromatography Purified)
BLA Number
: 125046
351(a)
Gammaked, Gamunex-C (Immune Globulin Injection (Human) 10% Caprylate/Chromatography Purified)
BLA Number
: 125046
351(a)
Gammaplex (Immune Globulin Intravenous (Human))
BLA Number
: 125329
351(a)
Gammaplex (Immune Globulin Intravenous (Human))
BLA Number
: 125329
351(a)
Gammaplex (Immune Globulin Intravenous (Human))
BLA Number
: 125329
351(a)
Gammaplex (Immune Globulin Intravenous (Human))
BLA Number
: 125329
351(a)
Gammaplex (Immune Globulin Intravenous (Human))
BLA Number
: 125329
351(a)
Gammaplex (Immune Globulin Intravenous (Human))
BLA Number
: 125329
351(a)
Gammaplex (Immune Globulin Intravenous (Human))
BLA Number
: 125329
351(a)
gammar i.v.,gammar-p i.v. (Immune Globulin Intravenous (Human))
BLA Number
: 103956
351(a)
gammar i.v.,gammar-p i.v. (Immune Globulin Intravenous (Human))
BLA Number
: 103956
351(a)
gammar i.v.,gammar-p i.v. (Immune Globulin Intravenous (Human))
BLA Number
: 103956
351(a)
gammar i.v.,gammar-p i.v. (Immune Globulin Intravenous (Human))
BLA Number
: 103956
351(a)
Gardasil (Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant)
BLA Number
: 125126
351(a)
Gardasil 9 (Human Papillomavirus 9-valent Vaccine, Recombinant)
BLA Number
: 125508
351(a)
Gardasil 9 (Human Papillomavirus 9-valent Vaccine, Recombinant)
BLA Number
: 125508
351(a)
Gazyva (obinutuzumab)
BLA Number
: 125486
351(a)
Genotropin (somatropin)
BLA Number
: 020280
351(a)
Genotropin (somatropin)
BLA Number
: 020280
351(a)
Genotropin (somatropin)
BLA Number
: 020280
351(a)
Genotropin (somatropin)
BLA Number
: 020280
351(a)
Genotropin (somatropin)
BLA Number
: 020280
351(a)
Genotropin (somatropin)
BLA Number
: 020280
351(a)
Genotropin (somatropin)
BLA Number
: 020280
351(a)
Genotropin (somatropin)
BLA Number
: 020280
351(a)
Genotropin (somatropin)
BLA Number
: 020280
351(a)
Genotropin (somatropin)
BLA Number
: 020280
351(a)
Genotropin (somatropin)
BLA Number
: 020280
351(a)
Genotropin (somatropin)
BLA Number
: 020280
351(a)
Genotropin (somatropin)
BLA Number
: 020280
351(a)
Gintuit (Allogeneic Cultured Keratinocytes and Fibroblasts in Bovine Collagen)
BLA Number
: 125400
351(a)
Glassia (Alpha-1-Proteinase Inhibitor (Human))
BLA Number
: 125325
351(a)
Glassia (Alpha-1-Proteinase Inhibitor (Human))
BLA Number
: 125325
351(a)
Glassia (Alpha-1-Proteinase Inhibitor (Human))
BLA Number
: 125325
351(a)
Gonal-f (follitropin alfa)
BLA Number
: 020378
351(a)
Gonal-f (follitropin alfa)
BLA Number
: 020378
351(a)
Gonal-f (follitropin alfa)
BLA Number
: 020378
351(a)
Gonal-f (follitropin alfa)
BLA Number
: 020378
351(a)
Gonal-f (follitropin alfa)
BLA Number
: 020378
351(a)
Gonal-f RFF (follitropin alfa)
BLA Number
: 021765
351(a)
Gonal-f RFF (follitropin alfa)
BLA Number
: 021765
351(a)
Gonal-f RFF (follitropin alfa)
BLA Number
: 021765
351(a)
Gonal-f RFF RediJect (follitropin alfa)
BLA Number
: 021684
351(a)
Gonal-f RFF RediJect (follitropin alfa)
BLA Number
: 021684
351(a)
Gonal-f RFF RediJect (follitropin alfa)
BLA Number
: 021684
351(a)
Granix (tbo-filgrastim)
BLA Number
: 125294
351(a)
Granix (tbo-filgrastim)
BLA Number
: 125294
351(a)
Granix (tbo-filgrastim)
BLA Number
: 125294
351(a)
Granix (tbo-filgrastim)
BLA Number
: 125294
351(a)
Grastek (Timothy Grass Pollen Allergen Extract)
BLA Number
: 125473
351(a)
Hadlima (adalimumab-bwwd)
BLA Number
: 761059
351(k) Interchangeable
Hadlima (adalimumab-bwwd)
BLA Number
: 761059
351(k) Interchangeable
Hadlima (adalimumab-bwwd)
BLA Number
: 761059
351(k) Interchangeable
Hadlima (adalimumab-bwwd)
BLA Number
: 761059
351(k) Interchangeable
Hadlima (adalimumab-bwwd)
BLA Number
: 761059
351(k) Interchangeable
Haegarda (C1 Esterase Inhibitor Subcutaneous (Human))
BLA Number
: 125606
351(a)
Haegarda (C1 Esterase Inhibitor Subcutaneous (Human))
BLA Number
: 125606
351(a)
Havrix (Hepatitis A Vaccine)
BLA Number
: 103475
351(a)
Havrix (Hepatitis A Vaccine)
BLA Number
: 103475
351(a)
Havrix (Hepatitis A Vaccine)
BLA Number
: 103475
351(a)
Havrix (Hepatitis A Vaccine)
BLA Number
: 103475
351(a)
Helixate Fs, Kogenate, Kogenate Fs (Antihemophilic Factor (Recombinant))
BLA Number
: 103332
351(a)
Helixate Fs, Kogenate, Kogenate Fs (Antihemophilic Factor (Recombinant))
BLA Number
: 103332
351(a)
Helixate Fs, Kogenate, Kogenate Fs (Antihemophilic Factor (Recombinant))
BLA Number
: 103332
351(a)
Helixate Fs, Kogenate, Kogenate Fs (Antihemophilic Factor (Recombinant))
BLA Number
: 103332
351(a)
Helixate Fs, Kogenate, Kogenate Fs (Antihemophilic Factor (Recombinant))
BLA Number
: 103332
351(a)
Hemacord (Hematopoietic Progenitor Cells, Cord (HPC-C))
BLA Number
: 125397
351(a)
Hemgenix (etranacogene dezaparvovec-drlb)
BLA Number
: 125772
351(a)
Hemlibra (emicizumab-kxwh)
BLA Number
: 761083
351(a)
Hemlibra (emicizumab-kxwh)
BLA Number
: 761083
351(a)
Hemlibra (emicizumab-kxwh)
BLA Number
: 761083
351(a)
Hemlibra (emicizumab-kxwh)
BLA Number
: 761083
351(a)
Hemlibra (emicizumab-kxwh)
BLA Number
: 761083
351(a)
Hemlibra (emicizumab-kxwh)
BLA Number
: 761083
351(a)
Hemofil M (Antihemophilic Factor (Human))
BLA Number
: 101448
351(a)
Hemofil M (Antihemophilic Factor (Human))
BLA Number
: 101448
351(a)
Hemofil M (Antihemophilic Factor (Human))
BLA Number
: 101448
351(a)
Hemofil M (Antihemophilic Factor (Human))
BLA Number
: 101448
351(a)
Hepagam B (Hepatitis B Immune Globulin (Human))
BLA Number
: 125035
351(a)
Hepagam B (Hepatitis B Immune Globulin (Human))
BLA Number
: 125035
351(a)
Heplisav-B (Hepatitis B Vaccine (Recombinant), Adjuvanted)
BLA Number
: 125428
351(a)
Herceptin (trastuzumab)
BLA Number
: 103792
351(a)
Herceptin (trastuzumab)
BLA Number
: 103792
351(a)
Herceptin Hylecta (trastuzumab and hyaluronidase-oysk)
BLA Number
: 761106
351(a)
Hercessi (trastuzumab-strf)
BLA Number
: 761346
351(k) Biosimilar
Hercessi (trastuzumab-strf)
BLA Number
: 761346
351(k) Biosimilar
Herzuma (trastuzumab-pkrb)
BLA Number
: 761091
351(k) Biosimilar
Herzuma (trastuzumab-pkrb)
BLA Number
: 761091
351(k) Biosimilar
Hiberix (Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate))
BLA Number
: 125347
351(a)
Histatrol (Positive Skin Test Control-Histamine)
BLA Number
: 103754
351(a)
Histatrol (Positive Skin Test Control-Histamine)
BLA Number
: 103754
351(a)
Hizentra (Immune Globulin Subcutaneous (Human), 20% Liquid)
BLA Number
: 125350
351(a)
Hizentra (Immune Globulin Subcutaneous (Human), 20% Liquid)
BLA Number
: 125350
351(a)
Hizentra (Immune Globulin Subcutaneous (Human), 20% Liquid)
BLA Number
: 125350
351(a)
Hizentra (Immune Globulin Subcutaneous (Human), 20% Liquid)
BLA Number
: 125350
351(a)
Hizentra (Immune Globulin Subcutaneous (Human), 20% Liquid)
BLA Number
: 125350
351(a)
hudquzco rubber panel,rubber panel t.r.u.e. test (Rubber Panel Thin-Layer Rapid Use Epicutaneous Patch Test)
BLA Number
: 125579
351(a)
Hulio (adalimumab-fkjp)
BLA Number
: 761154
351(k) Interchangeable
Hulio (adalimumab-fkjp)
BLA Number
: 761154
351(k) Interchangeable
Hulio (adalimumab-fkjp)
BLA Number
: 761154
351(k) Interchangeable
Humalog (insulin lispro)
BLA Number
: 020563
351(a)
Humalog (insulin lispro)
BLA Number
: 020563
351(a)
Humalog (insulin lispro)
BLA Number
: 020563
351(a)
Humalog (insulin lispro)
BLA Number
: 020563
351(a)
Humalog (insulin lispro)
BLA Number
: 205747
351(a)
Humalog (insulin lispro)
BLA Number
: 205747
351(a)
Humalog (insulin lispro)
BLA Number
: 020563
351(a)
Humalog (insulin lispro)
BLA Number
: 020563
351(a)
Humalog Mix 50/50 (insulin lispro protamine and insulin lispro)
BLA Number
: 021018
351(a)
Humalog Mix 50/50 (insulin lispro protamine and insulin lispro)
BLA Number
: 021018
351(a)
Humalog Mix 50/50 (insulin lispro protamine and insulin lispro)
BLA Number
: 021018
351(a)
Humalog Mix 75/25 (insulin lispro protamine and insulin lispro)
BLA Number
: 021017
351(a)
Humalog Mix 75/25 (insulin lispro protamine and insulin lispro)
BLA Number
: 021017
351(a)
Humalog Mix 75/25 (insulin lispro protamine and insulin lispro)
BLA Number
: 021017
351(a)
Human Albumin Grifols (Albumin (Human))
BLA Number
: 103352
351(a)
Human Albumin Grifols (Albumin (Human))
BLA Number
: 103352
351(a)
Human Albumin Grifols (Albumin (Human))
BLA Number
: 103352
351(a)
Human Albumin Grifols (Albumin (Human))
BLA Number
: 103352
351(a)
Humate-P (Antihemophilic Factor/von Willebrand Factor Complex (Human))
BLA Number
: 103960
351(a)
Humate-P (Antihemophilic Factor/von Willebrand Factor Complex (Human))
BLA Number
: 103960
351(a)
Humate-P (Antihemophilic Factor/von Willebrand Factor Complex (Human))
BLA Number
: 103960
351(a)
Humatrope (somatropin)
BLA Number
: 019640
351(a)
Humatrope (somatropin)
BLA Number
: 019640
351(a)
Humatrope (somatropin)
BLA Number
: 019640
351(a)
Humatrope (somatropin)
BLA Number
: 019640
351(a)
Humatrope (somatropin)
BLA Number
: 019640
351(a)
Humegon (menotropins)
BLA Number
: 020328
351(a)
Humegon (menotropins)
BLA Number
: 020328
351(a)
Humira (adalimumab)
BLA Number
: 125057
351(a)
Humira (adalimumab)
BLA Number
: 125057
351(a)
Humira (adalimumab)
BLA Number
: 125057
351(a)
Humira (adalimumab)
BLA Number
: 125057
351(a)
Humira (adalimumab)
BLA Number
: 125057
351(a)
Humira (adalimumab)
BLA Number
: 125057
351(a)
Humira (adalimumab)
BLA Number
: 125057
351(a)
Humira (adalimumab)
BLA Number
: 125057
351(a)
Humira (adalimumab)
BLA Number
: 125057
351(a)
Humira (adalimumab)
BLA Number
: 125057
351(a)
Humira (adalimumab)
BLA Number
: 125057
351(a)
Humulin 70/30 (insulin isophane human and insulin human)
BLA Number
: 019717
351(a)
Humulin 70/30 (insulin isophane human and insulin human)
BLA Number
: 019717
351(a)
Humulin 70/30 (insulin isophane human and insulin human)
BLA Number
: 019717
351(a)
Humulin N (insulin isophane human)
BLA Number
: 018781
351(a)
Humulin N (insulin isophane human)
BLA Number
: 018781
351(a)
Humulin N (insulin isophane human)
BLA Number
: 018781
351(a)
Humulin R U-100 (insulin human)
BLA Number
: 018780
351(a)
Humulin R U-100 (insulin human)
BLA Number
: 018780
351(a)
Humulin R U-100 (insulin human)
BLA Number
: 018780
351(a)
Humulin R U-500 (insulin human)
BLA Number
: 018780
351(a)
Humulin R U-500 (insulin human)
BLA Number
: 018780
351(a)
Hydase (hyaluronidase)
BLA Number
: 021716
351(a)
Hylenex recombinant (hyaluronidase human)
BLA Number
: 021859
351(a)
Hympavzi (marstacimab-hncq)
BLA Number
: 761369
351(a)
Hympavzi (marstacimab-hncq)
BLA Number
: 761369
351(a)
Hyqvia (Immune Globulin Infusion (Human), 10% with Recombinant Human Hyaluronidase)
BLA Number
: 125402
351(a)
Hyrimoz (adalimumab-adaz)
BLA Number
: 761071
351(k) Interchangeable
Hyrimoz (adalimumab-adaz)
BLA Number
: 761071
351(k) Interchangeable
Hyrimoz (adalimumab-adaz)
BLA Number
: 761071
351(k) Interchangeable
Hyrimoz (adalimumab-adaz)
BLA Number
: 761071
351(k) Interchangeable
Hyrimoz (adalimumab-adaz)
BLA Number
: 761071
351(k) Interchangeable
Hyrimoz (adalimumab-adaz)
BLA Number
: 761071
351(k) Interchangeable
Hyrimoz (adalimumab-adaz)
BLA Number
: 761071
351(k) Interchangeable
Hyrimoz (adalimumab-adaz)
BLA Number
: 761071
351(k) Interchangeable
Hyrimoz (adalimumab-adaz)
BLA Number
: 761071
351(k) Interchangeable
Hyrimoz (adalimumab-adaz)
BLA Number
: 761071
351(k) Interchangeable
Idacio (adalimumab-aacf)
BLA Number
: 761255
351(k) Biosimilar
Idacio (adalimumab-aacf)
BLA Number
: 761255
351(k) Biosimilar
Idacio (adalimumab-aacf)
BLA Number
: 761255
351(k) Biosimilar
Idelvion (Coagulation Factor IX (Recombinant), Albumin Fusion Protein)
BLA Number
: 125582
351(a)
Idelvion (Coagulation Factor IX (Recombinant), Albumin Fusion Protein)
BLA Number
: 125582
351(a)
Idelvion (Coagulation Factor IX (Recombinant), Albumin Fusion Protein)
BLA Number
: 125582
351(a)
Idelvion (Coagulation Factor IX (Recombinant), Albumin Fusion Protein)
BLA Number
: 125582
351(a)
Idelvion (Coagulation Factor IX (Recombinant), Albumin Fusion Protein)
BLA Number
: 125582
351(a)
Ilaris (canakinumab)
BLA Number
: 125319
351(a)
Ilaris (canakinumab)
BLA Number
: 125319
351(a)
Ilumya (tildrakizumab-asmn)
BLA Number
: 761067
351(a)
Imaavy (nipocalimab-aahu)
BLA Number
: 761430
351(a)
Imaavy (nipocalimab-aahu)
BLA Number
: 761430
351(a)
Imdelltra (tarlatamab-dlle)
BLA Number
: 761344
351(a)
Imdelltra (tarlatamab-dlle)
BLA Number
: 761344
351(a)
Imfinzi (durvalumab)
BLA Number
: 761069
351(a)
Imfinzi (durvalumab)
BLA Number
: 761069
351(a)
Imjudo (tremelimumab-actl)
BLA Number
: 761289
351(a)
Imjudo (tremelimumab-actl)
BLA Number
: 761289
351(a)
Imlygic (Talimogene laherparepvec)
BLA Number
: 125518
351(a)
Imlygic (Talimogene laherparepvec)
BLA Number
: 125518
351(a)
Imogam (Rabies Immune Globulin (Human))
BLA Number
: 103932
351(a)
Imovax Rabies (Rabies Vaccine)
BLA Number
: 103931
351(a)
Imuldosa (ustekinumab-srlf)
BLA Number
: 761364
351(k) Biosimilar
Imuldosa (ustekinumab-srlf)
BLA Number
: 761364
351(k) Biosimilar
Imuldosa (ustekinumab-srlf)
BLA Number
: 761364
351(k) Biosimilar
Increlex (mecasermin)
BLA Number
: 021839
351(a)
Infanrix (Diphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine Adsorbed)
BLA Number
: 103647
351(a)
Infanrix (Diphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine Adsorbed)
BLA Number
: 103647
351(a)
Infasurf (calfactant)
BLA Number
: 020521
351(a)
Infasurf (calfactant)
BLA Number
: 020521
351(a)
Infergen (interferon alfacon-1)
BLA Number
: 103663
351(a)
Inflectra (infliximab-dyyb)
BLA Number
: 125544
351(k) Biosimilar
Inmazeb (atoltivimab, maftivimab, and odesivimab-ebgn)
BLA Number
: 761169
351(a)
Inmazeb (atoltivimab, maftivimab, and odesivimab-ebgn)
BLA Number
: 761169
351(a)
Intron A (interferon alfa-2b)
BLA Number
: 103132
351(a)
Intron A (interferon alfa-2b)
BLA Number
: 103132
351(a)
Intron A (interferon alfa-2b)
BLA Number
: 103132
351(a)
Intron A (interferon alfa-2b)
BLA Number
: 103132
351(a)
Intron A (interferon alfa-2b)
BLA Number
: 103132
351(a)
Intron A (interferon alfa-2b)
BLA Number
: 103132
351(a)
Intron A (interferon alfa-2b)
BLA Number
: 103132
351(a)
Intron A (interferon alfa-2b)
BLA Number
: 103132
351(a)
Intron A (interferon alfa-2b)
BLA Number
: 103132
351(a)
Intron A (interferon alfa-2b)
BLA Number
: 103132
351(a)
Intron A (interferon alfa-2b)
BLA Number
: 103132
351(a)
Intron A (interferon alfa-2b)
BLA Number
: 103132
351(a)
Intron A (interferon alfa-2b)
BLA Number
: 103132
351(a)
Intron A (interferon alfa-2b)
BLA Number
: 103132
351(a)
Iplex (mecasermin rinfabate)
BLA Number
: 021884
351(a)
Ipol (Poliovirus Vaccine Inactivated)
BLA Number
: 103930
351(a)
Ipol (Poliovirus Vaccine Inactivated)
BLA Number
: 103930
351(a)
Iprivask (desirudin)
BLA Number
: 021271
351(a)
ITVISMA (onasemnogene abeparvovec-brve)
BLA Number
: 125856
351(a)
IXCHIQ (Chikungunya Vaccine, Live)
BLA Number
: 125777
351(a)
Ixiaro (Japanese Encephalitis Vaccine, Inactivated, Adsorbed)
BLA Number
: 125280
351(a)
Ixifi (infliximab-qbtx)
BLA Number
: 761072
351(k) Biosimilar
Ixinity (Coagulation Factor IX (Recombinant))
BLA Number
: 125426
351(a)
Ixinity (Coagulation Factor IX (Recombinant))
BLA Number
: 125426
351(a)
Ixinity (Coagulation Factor IX (Recombinant))
BLA Number
: 125426
351(a)
Ixinity (Coagulation Factor IX (Recombinant))
BLA Number
: 125426
351(a)
Ixinity (Coagulation Factor IX (Recombinant))
BLA Number
: 125426
351(a)
Ixinity (Coagulation Factor IX (Recombinant))
BLA Number
: 125426
351(a)
Jeanatope (iodinated I-125 albumin)
BLA Number
: 017836
351(a)
Jeanatope (iodinated I-125 albumin)
BLA Number
: 017836
351(a)
Jeanatope (iodinated I-125 albumin)
BLA Number
: 017836
351(a)
Jemperli (dostarlimab-gxly)
BLA Number
: 761174
351(a)
Jetrea (ocriplasmin)
BLA Number
: 125422
351(a)
Jetrea (ocriplasmin)
BLA Number
: 125422
351(a)
Jeuveau (prabotulinumtoxinA-xvfs)
BLA Number
: 761085
351(a)
Jivi (Antihemophilic factor (recombinant), PEGylated-aucl)
BLA Number
: 125661
351(a)
Jivi (Antihemophilic factor (recombinant), PEGylated-aucl)
BLA Number
: 125661
351(a)
Jivi (Antihemophilic factor (recombinant), PEGylated-aucl)
BLA Number
: 125661
351(a)
Jivi (Antihemophilic factor (recombinant), PEGylated-aucl)
BLA Number
: 125661
351(a)
Jivi (Antihemophilic factor (recombinant), PEGylated-aucl)
BLA Number
: 125661
351(a)
Jobevne (bevacizumab-nwgd)
BLA Number
: 761175
351(k) Biosimilar
Jobevne (bevacizumab-nwgd)
BLA Number
: 761175
351(k) Biosimilar
Jubbonti (denosumab-bbdz)
BLA Number
: 761362
351(k) Interchangeable
Jubereq (denosumab-desu)
BLA Number
: 761424
351(k) Interchangeable
Jynneos (Smallpox and Mpox Vaccine, Live, Non-replicating)
BLA Number
: 125678
351(a)
Jynneos (Smallpox and Mpox Vaccine, Live, Non-replicating)
BLA Number
: 125678
351(a)
Kadcyla (ado-trastuzumab emtansine)
BLA Number
: 125427
351(a)
Kadcyla (ado-trastuzumab emtansine)
BLA Number
: 125427
351(a)
Kalbitor (ecallantide)
BLA Number
: 125277
351(a)
Kanjinti (trastuzumab-anns)
BLA Number
: 761073
351(k) Biosimilar
Kanjinti (trastuzumab-anns)
BLA Number
: 761073
351(k) Biosimilar
Kanuma (sebelipase alfa)
BLA Number
: 125561
351(a)
Kcentra (Prothrombin Complex Concentrate (Human))
BLA Number
: 125421
351(a)
Kcentra (Prothrombin Complex Concentrate (Human))
BLA Number
: 125421
351(a)
KEBILIDI (eladocagene exuparvovec-tneq)
BLA Number
: 125722
351(a)
Kedbumin (Albumin (Human))
BLA Number
: 125384
351(a)
Kedbumin (Albumin (Human))
BLA Number
: 125384
351(a)
Kedrab (Rabies Immune Globulin (Human))
BLA Number
: 125613
351(a)
Kepivance (palifermin)
BLA Number
: 125103
351(a)
Kesimpta (ofatumumab)
BLA Number
: 125326
351(a)
Kesimpta (ofatumumab)
BLA Number
: 125326
351(a)
Kevzara (sarilumab)
BLA Number
: 761037
351(a)
Kevzara (sarilumab)
BLA Number
: 761037
351(a)
Kevzara (sarilumab)
BLA Number
: 761037
351(a)
Kevzara (sarilumab)
BLA Number
: 761037
351(a)
Keytruda (pembrolizumab)
BLA Number
: 125514
351(a)
Keytruda (pembrolizumab)
BLA Number
: 125514
351(a)
Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph)
BLA Number
: 761467
351(a)
Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph)
BLA Number
: 761467
351(a)
Kimmtrak (tebentafusp-tebn)
BLA Number
: 761228
351(a)
Kineret (anakinra)
BLA Number
: 103950
351(a)
Kinlytic (urokinase)
BLA Number
: 021846
351(a)
Kinlytic (urokinase)
BLA Number
: 021846
351(a)
Kinlytic (urokinase)
BLA Number
: 021846
351(a)
Kinrix (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine)
BLA Number
: 125260
351(a)
Kirsty (insulin aspart-xjhz)
BLA Number
: 761188
351(k) Interchangeable
Kirsty (insulin aspart-xjhz)
BLA Number
: 761188
351(k) Interchangeable
Kisunla (donanemab-azbt)
BLA Number
: 761248
351(a)
Koate, Koate-Dvi (Antihemophilic Factor (Human))
BLA Number
: 101130
351(a)
Koate, Koate-Dvi (Antihemophilic Factor (Human))
BLA Number
: 101130
351(a)
Koate, Koate-Dvi (Antihemophilic Factor (Human))
BLA Number
: 101130
351(a)
Kovaltry (Antihemophilic Factor (Recombinant), Full Length)
BLA Number
: 125574
351(a)
Kovaltry (Antihemophilic Factor (Recombinant), Full Length)
BLA Number
: 125574
351(a)
Kovaltry (Antihemophilic Factor (Recombinant), Full Length)
BLA Number
: 125574
351(a)
Kovaltry (Antihemophilic Factor (Recombinant), Full Length)
BLA Number
: 125574
351(a)
Kovaltry (Antihemophilic Factor (Recombinant), Full Length)
BLA Number
: 125574
351(a)
kresladi (marnetegragene autotemcel)
BLA Number
: 125806
351(a)
Krystexxa (pegloticase)
BLA Number
: 125293
351(a)
Krystexxa (pegloticase)
BLA Number
: 125293
351(a)
Kymriah (tisagenlecleucel)
BLA Number
: 125646
351(a)
Lamzede (velmanase alfa-tycv)
BLA Number
: 761278
351(a)
Lantidra (donislecel-jujn)
BLA Number
: 125734
351(a)
Lantus (insulin glargine)
BLA Number
: 021081
351(a)
Lantus (insulin glargine)
BLA Number
: 021081
351(a)
Lantus (insulin glargine)
BLA Number
: 021081
351(a)
Lantus (insulin glargine)
BLA Number
: 021081
351(a)
Lartruvo (olaratumab)
BLA Number
: 761038
351(a)
Lartruvo (olaratumab)
BLA Number
: 761038
351(a)
Laviv (Azficel-T)
BLA Number
: 125348
351(a)
Lemtrada (alemtuzumab)
BLA Number
: 103948
351(a)
Lenmeldy (atidarsagene autotemcel)
BLA Number
: 125758
351(a)
Leqembi (lecanemab-irmb)
BLA Number
: 761269
351(a)
Leqembi (lecanemab-irmb)
BLA Number
: 761269
351(a)
Leqembi IQLIK (lecanemab-irmb)
BLA Number
: 761375
351(a)
Lerochol (lerodalcibep-liga)
BLA Number
: 761427
351(a)
Letybo (letibotulinumtoxinA-wlbg)
BLA Number
: 761225
351(a)
Letybo (letibotulinumtoxinA-wlbg)
BLA Number
: 761225
351(a)
Leukine (sargramostim)
BLA Number
: 103362
351(a)
Leukine (sargramostim)
BLA Number
: 103362
351(a)
Levemir (insulin detemir)
BLA Number
: 021536
351(a)
Levemir (insulin detemir)
BLA Number
: 021536
351(a)
Levemir (insulin detemir)
BLA Number
: 021536
351(a)
Levemir (insulin detemir)
BLA Number
: 021536
351(a)
Levemir (insulin detemir)
BLA Number
: 021536
351(a)
Libtayo (cemiplimab-rwlc)
BLA Number
: 761097
351(a)
Loargys (pegzilarginase-nbln)
BLA Number
: 761211
351(a)
Loargys (pegzilarginase-nbln)
BLA Number
: 761211
351(a)
Loqtorzi (toripalimab-tpzi)
BLA Number
: 761240
351(a)
Lucentis (ranibizumab)
BLA Number
: 125156
351(a)
Lucentis (ranibizumab)
BLA Number
: 125156
351(a)
Lucentis (ranibizumab)
BLA Number
: 125156
351(a)
Lucentis (ranibizumab)
BLA Number
: 125156
351(a)
Lumizyme (alglucosidase alfa)
BLA Number
: 125291
351(a)
Lumoxiti (moxetumomab pasudotox-tdfk)
BLA Number
: 761104
351(a)
Lunsumio (mosunetuzumab-axgb)
BLA Number
: 761263
351(a)
Lunsumio (mosunetuzumab-axgb)
BLA Number
: 761263
351(a)
Lunsumio Velo (mosunetuzumab-axgb)
BLA Number
: 761263
351(a)
Lunsumio Velo (mosunetuzumab-axgb)
BLA Number
: 761263
351(a)
Luxturna (Voretigene Neparvovec)
BLA Number
: 125610
351(a)
LYFGENIA (lovotibeglogene autotemcel)
BLA Number
: 125788
351(a)
Lymphir (denileukin diftitox-cxdl)
BLA Number
: 761312
351(a)
Lynozyfic (linvoseltamab-gcpt)
BLA Number
: 761400
351(a)
Lynozyfic (linvoseltamab-gcpt)
BLA Number
: 761400
351(a)
Lyumjev (insulin lispro-aabc)
BLA Number
: 761109
351(a)
Lyumjev (insulin lispro-aabc)
BLA Number
: 761109
351(a)
Lyumjev (insulin lispro-aabc)
BLA Number
: 761109
351(a)
Lyumjev (insulin lispro-aabc)
BLA Number
: 761109
351(a)
Lyumjev (insulin lispro-aabc)
BLA Number
: 761109
351(a)
Lyumjev (insulin lispro-aabc)
BLA Number
: 761109
351(a)
M-M-R Ii (Measles, Mumps and Rubella Virus Vaccine Live)
BLA Number
: 101069
351(a)
M-M-R Ii (Measles, Mumps and Rubella Virus Vaccine Live)
BLA Number
: 101069
351(a)
Maci (autologous cultured chondrocytes on porcine collagen membrane)
BLA Number
: 125603
351(a)
Macrotec (kit for the preparation of technetium Tc-99m albumin aggregated)
BLA Number
: 017833
351(a)
Margenza (margetuximab-cmkb)
BLA Number
: 761150
351(a)
Megatope (iodinated I-131 albumin)
BLA Number
: 017837
351(a)
Megatope (iodinated I-131 albumin)
BLA Number
: 017837
351(a)
Megatope (iodinated I-131 albumin)
BLA Number
: 017837
351(a)
Megatope (iodinated I-131 albumin)
BLA Number
: 017837
351(a)
Megatope (iodinated I-131 albumin)
BLA Number
: 017837
351(a)
Menactra (Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine)
BLA Number
: 125089
351(a)
MENHIBRIX (Meningococcal Groups C and Y and Haemophilus b Tetanus Toxoid Conjugate Vaccine)
BLA Number
: 125363
351(a)
Menomune (Meningococcal Polysaccharide Vaccine, Groups A, C, Y, and W-135 Combined)
BLA Number
: 103926
351(a)
Menomune-A (Meningococcal Polysaccharide Vaccine, Group A)
BLA Number
: 103924
351(a)
Menomune-A/C (Meningococcal Polysaccharide Vaccine, Groups A and C Combined)
BLA Number
: 103925
351(a)
Menomune-A/C (Meningococcal Polysaccharide Vaccine, Groups A and C Combined)
BLA Number
: 103925
351(a)
Menomune-C (Meningococcal Polysaccharide Vaccine, Group C)
BLA Number
: 103923
351(a)
Menopur (menotropins)
BLA Number
: 021663
351(a)
Menquadfi (Meningococcal (Groups A, C, Y, W) Conjugate Vaccine)
BLA Number
: 125701
351(a)
Menveo (Meningococcal (Groups A, C, Y, and W-135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine)
BLA Number
: 125300
351(a)
Menveo (Meningococcal (Groups A, C, Y, and W-135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine)
BLA Number
: 125300
351(a)
Mepsevii (vestronidase alfa-vjbk)
BLA Number
: 761047
351(a)
Merilog (insulin aspart-szjj)
BLA Number
: 761325
351(k) Biosimilar
Merilog (insulin aspart-szjj)
BLA Number
: 761325
351(k) Biosimilar
MERUVAX II (Rubella Virus Vaccine Live)
BLA Number
: 101075
351(a)
Micrhogam, Rhogam (Rho(D) Immune Globulin (Human))
BLA Number
: 103777
351(a)
Micrhogam, Rhogam (Rho(D) Immune Globulin (Human))
BLA Number
: 103777
351(a)
Microlite (radiolabeled albumin technetium Tc-99m albumin colloid kit)
BLA Number
: 018263
351(a)
Mircera (methoxy polyethylene glycol-epoetin beta)
BLA Number
: 125164
351(a)
Mircera (methoxy polyethylene glycol-epoetin beta)
BLA Number
: 125164
351(a)
Mircera (methoxy polyethylene glycol-epoetin beta)
BLA Number
: 125164
351(a)
Mircera (methoxy polyethylene glycol-epoetin beta)
BLA Number
: 125164
351(a)
Mircera (methoxy polyethylene glycol-epoetin beta)
BLA Number
: 125164
351(a)
Mircera (methoxy polyethylene glycol-epoetin beta)
BLA Number
: 125164
351(a)
Mircera (methoxy polyethylene glycol-epoetin beta)
BLA Number
: 125164
351(a)
Mircera (methoxy polyethylene glycol-epoetin beta)
BLA Number
: 125164
351(a)
Mircera (methoxy polyethylene glycol-epoetin beta)
BLA Number
: 125164
351(a)
Mircera (methoxy polyethylene glycol-epoetin beta)
BLA Number
: 125164
351(a)
Mircera (methoxy polyethylene glycol-epoetin beta)
BLA Number
: 125164
351(a)
Mircera (methoxy polyethylene glycol-epoetin beta)
BLA Number
: 125164
351(a)
Mircera (methoxy polyethylene glycol-epoetin beta)
BLA Number
: 125164
351(a)
Mircera (methoxy polyethylene glycol-epoetin beta)
BLA Number
: 125164
351(a)
Mircera (methoxy polyethylene glycol-epoetin beta)
BLA Number
: 125164
351(a)
Mircera (methoxy polyethylene glycol-epoetin beta)
BLA Number
: 125164
351(a)
Mircera (methoxy polyethylene glycol-epoetin beta)
BLA Number
: 125164
351(a)
Mircera (methoxy polyethylene glycol-epoetin beta)
BLA Number
: 125164
351(a)
Mircera (methoxy polyethylene glycol-epoetin beta)
BLA Number
: 125164
351(a)
mnexspike (COVID-19 Vaccine, mRNA)
BLA Number
: 125835
351(a)
Monjuvi (tafasitamab-cxix)
BLA Number
: 761163
351(a)
Monoclate, Monoclate-P (Antihemophilic Factor (Human))
BLA Number
: 103953
351(a)
Monoclate, Monoclate-P (Antihemophilic Factor (Human))
BLA Number
: 103953
351(a)
Monoclate, Monoclate-P (Antihemophilic Factor (Human))
BLA Number
: 103953
351(a)
Monoclate, Monoclate-P (Antihemophilic Factor (Human))
BLA Number
: 103953
351(a)
Mononine (Coagulation Factor IX (Human))
BLA Number
: 103957
351(a)
Mononine (Coagulation Factor IX (Human))
BLA Number
: 103957
351(a)
mresvia (Respiratory Syncytial Virus Vaccine)
BLA Number
: 125796
351(a)
MumpsVax (Mumps Virus Vaccine Live)
BLA Number
: 101072
351(a)
Mvasi (bevacizumab-awwb)
BLA Number
: 761028
351(k) Biosimilar
Mvasi (bevacizumab-awwb)
BLA Number
: 761028
351(k) Biosimilar
Myalept (metreleptin)
BLA Number
: 125390
351(a)
Mycobax (BCG Vaccine)
BLA Number
: 103942
351(a)
Mylotarg (gemtuzumab ozogamicin)
BLA Number
: 761060
351(a)
Myobloc (rimabotulinumtoxinB)
BLA Number
: 103846
351(a)
Myobloc (rimabotulinumtoxinB)
BLA Number
: 103846
351(a)
Myobloc (rimabotulinumtoxinB)
BLA Number
: 103846
351(a)
Myozyme (alglucosidase alfa)
BLA Number
: 125141
351(a)
Myxredlin (insulin human )
BLA Number
: 208157
351(a)
Nabi-HB (Hepatitis B Immune Globulin (Human))
BLA Number
: 103945
351(a)
Nabi-HB (Hepatitis B Immune Globulin (Human))
BLA Number
: 103945
351(a)
Naglazyme (galsulfase )
BLA Number
: 125117
351(a)
Natpara (parathyroid hormone)
BLA Number
: 125511
351(a)
Natpara (parathyroid hormone)
BLA Number
: 125511
351(a)
Natpara (parathyroid hormone)
BLA Number
: 125511
351(a)
Natpara (parathyroid hormone)
BLA Number
: 125511
351(a)
Nemluvio (nemolizumab-ilto)
BLA Number
: 761390
351(a)
Neulasta (pegfilgrastim)
BLA Number
: 125031
351(a)
Neulasta Onpro (pegfilgrastim)
BLA Number
: 125031
351(a)
Neumega (oprelvekin)
BLA Number
: 103694
351(a)
Neupogen (filgrastim)
BLA Number
: 103353
351(a)
Neupogen (filgrastim)
BLA Number
: 103353
351(a)
Neupogen (filgrastim)
BLA Number
: 103353
351(a)
Neupogen (filgrastim)
BLA Number
: 103353
351(a)
NeutroSpec (technetium 99m tc fanolesomab)
BLA Number
: 103928
351(a)
Nexobrid (anacaulase-bcdb)
BLA Number
: 761192
351(a)
Nexobrid (anacaulase-bcdb)
BLA Number
: 761192
351(a)
Nexviazyme (avalglucosidase alfa-ngpt)
BLA Number
: 761194
351(a)
Ngenla (somatrogon-ghla)
BLA Number
: 761184
351(a)
Ngenla (somatrogon-ghla)
BLA Number
: 761184
351(a)
Niktimvo (axatilimab-csfr)
BLA Number
: 761411
351(a)
Nivestym (filgrastim-aafi)
BLA Number
: 761080
351(k) Biosimilar
Nivestym (filgrastim-aafi)
BLA Number
: 761080
351(k) Biosimilar
Nivestym (filgrastim-aafi)
BLA Number
: 761080
351(k) Biosimilar
Nivestym (filgrastim-aafi)
BLA Number
: 761080
351(k) Biosimilar
Norditropin (somatropin)
BLA Number
: 021148
351(a)
Norditropin (somatropin)
BLA Number
: 021148
351(a)
Norditropin (somatropin)
BLA Number
: 021148
351(a)
Norditropin (somatropin)
BLA Number
: 021148
351(a)
Norditropin (somatropin)
BLA Number
: 021148
351(a)
Norditropin (somatropin)
BLA Number
: 021148
351(a)
Norditropin (somatropin)
BLA Number
: 021148
351(a)
Norditropin (somatropin)
BLA Number
: 021148
351(a)
Norditropin (somatropin)
BLA Number
: 021148
351(a)
Norditropin (somatropin)
BLA Number
: 021148
351(a)
Norditropin (somatropin)
BLA Number
: 021148
351(a)
Novarel (chorionic gonadotropin)
BLA Number
: 017016
351(a)
Novarel (chorionic gonadotropin)
BLA Number
: 017016
351(a)
Novarel (chorionic gonadotropin)
BLA Number
: 017016
351(a)
Novarel (chorionic gonadotropin)
BLA Number
: 017016
351(a)
Novarel (chorionic gonadotropin)
BLA Number
: 017016
351(a)
Novarel (chorionic gonadotropin)
BLA Number
: 017016
351(a)
Novoeight (Antihemophilic Factor (Recombinant))
BLA Number
: 125466
351(a)
Novoeight (Antihemophilic Factor (Recombinant))
BLA Number
: 125466
351(a)
Novoeight (Antihemophilic Factor (Recombinant))
BLA Number
: 125466
351(a)
Novoeight (Antihemophilic Factor (Recombinant))
BLA Number
: 125466
351(a)
Novoeight (Antihemophilic Factor (Recombinant))
BLA Number
: 125466
351(a)
Novoeight (Antihemophilic Factor (Recombinant))
BLA Number
: 125466
351(a)
Novolin 70/30 (insulin isophane human and insulin human)
BLA Number
: 019991
351(a)
Novolin 70/30 (insulin isophane human and insulin human)
BLA Number
: 019991
351(a)
Novolin N (insulin isophane human)
BLA Number
: 019959
351(a)
Novolin N (insulin isophane human)
BLA Number
: 019959
351(a)
Novolin R (insulin human)
BLA Number
: 019938
351(a)
Novolin R (insulin human)
BLA Number
: 019938
351(a)
Novolog (insulin aspart)
BLA Number
: 020986
351(a)
Novolog (insulin aspart)
BLA Number
: 020986
351(a)
Novolog (insulin aspart)
BLA Number
: 020986
351(a)
Novolog (insulin aspart)
BLA Number
: 020986
351(a)
Novolog (insulin aspart)
BLA Number
: 020986
351(a)
Novolog Mix 50/50 (insulin aspart protamine and insulin aspart)
BLA Number
: 021810
351(a)
Novolog Mix 50/50 (insulin aspart protamine and insulin aspart)
BLA Number
: 021810
351(a)
Novolog Mix 70/30 (insulin aspart protamine and insulin aspart)
BLA Number
: 021172
351(a)
Novolog Mix 70/30 (insulin aspart protamine and insulin aspart)
BLA Number
: 021172
351(a)
Novolog Mix 70/30 (insulin aspart protamine and insulin aspart)
BLA Number
: 021172
351(a)
Novolog Mix 70/30 (insulin aspart protamine and insulin aspart)
BLA Number
: 021172
351(a)
Novoseven, Novoseven Rt (Coagulation Factor VIIa (Recombinant))
BLA Number
: 103665
351(a)
Novoseven, Novoseven Rt (Coagulation Factor VIIa (Recombinant))
BLA Number
: 103665
351(a)
Novoseven, Novoseven Rt (Coagulation Factor VIIa (Recombinant))
BLA Number
: 103665
351(a)
Novoseven, Novoseven Rt (Coagulation Factor VIIa (Recombinant))
BLA Number
: 103665
351(a)
Novoseven, Novoseven Rt (Coagulation Factor VIIa (Recombinant))
BLA Number
: 103665
351(a)
Novoseven, Novoseven Rt (Coagulation Factor VIIa (Recombinant))
BLA Number
: 103665
351(a)
Novoseven, Novoseven Rt (Coagulation Factor VIIa (Recombinant))
BLA Number
: 103665
351(a)
Nplate (romiplostim)
BLA Number
: 125268
351(a)
Nplate (romiplostim)
BLA Number
: 125268
351(a)
Nplate (romiplostim)
BLA Number
: 125268
351(a)
Nucala (mepolizumab)
BLA Number
: 125526
351(a)
Nucala (mepolizumab)
BLA Number
: 125526
351(a)
Nucala (mepolizumab)
BLA Number
: 125526
351(a)
Nucala (mepolizumab)
BLA Number
: 761122
351(a)
Nucala (mepolizumab)
BLA Number
: 761122
351(a)
Nucala (mepolizumab)
BLA Number
: 761122
351(a)
Nucala (mepolizumab)
BLA Number
: 125526
351(a)
Nucala (mepolizumab)
BLA Number
: 761122
351(a)
Nufymco (ranibizumab-leyk)
BLA Number
: 761473
351(k) Interchangeable
Nufymco (ranibizumab-leyk)
BLA Number
: 761473
351(k) Interchangeable
Nulojix (belatacept)
BLA Number
: 125288
351(a)
Nutropin (somatropin)
BLA Number
: 020168
351(a)
Nutropin (somatropin)
BLA Number
: 020168
351(a)
Nutropin AQ (somatropin)
BLA Number
: 020522
351(a)
Nutropin AQ (somatropin)
BLA Number
: 020522
351(a)
Nutropin AQ (somatropin)
BLA Number
: 020522
351(a)
Nutropin AQ (somatropin)
BLA Number
: 020522
351(a)
Nutropin AQ (somatropin)
BLA Number
: 020522
351(a)
Nutropin AQ (somatropin)
BLA Number
: 020522
351(a)
NUVAXOVID (COVID-19 Vaccine, Adjuvanted)
BLA Number
: 125817
351(a)
Nuwiq (Antihemophilic Factor (Recombinant))
BLA Number
: 125555
351(a)
Nuwiq (Antihemophilic Factor (Recombinant))
BLA Number
: 125555
351(a)
Nuwiq (Antihemophilic Factor (Recombinant))
BLA Number
: 125555
351(a)
Nuwiq (Antihemophilic Factor (Recombinant))
BLA Number
: 125555
351(a)
Nuwiq (Antihemophilic Factor (Recombinant))
BLA Number
: 125555
351(a)
Nuwiq (Antihemophilic Factor (Recombinant))
BLA Number
: 125555
351(a)
Nuwiq (Antihemophilic Factor (Recombinant))
BLA Number
: 125555
351(a)
Nuwiq (Antihemophilic Factor (Recombinant))
BLA Number
: 125555
351(a)
Nypozi (filgrastim-txid)
BLA Number
: 761126
351(k) Biosimilar
Nypozi (filgrastim-txid)
BLA Number
: 761126
351(k) Biosimilar
Nyvepria (pegfilgrastim-apgf)
BLA Number
: 761111
351(k) Biosimilar
Obizur (Antihemophilic Factor (Recombinant), Porcine Sequence)
BLA Number
: 125512
351(a)
Ocrevus (ocrelizumab)
BLA Number
: 761053
351(a)
Ocrevus Zunovo (ocrelizumab and hyaluronidase-ocsq)
BLA Number
: 761371
351(a)
Octagam (Immune Globulin Intravenous (Human))
BLA Number
: 125062
351(a)
Octagam (Immune Globulin Intravenous (Human))
BLA Number
: 125062
351(a)
Octagam (Immune Globulin Intravenous (Human))
BLA Number
: 125062
351(a)
Octagam (Immune Globulin Intravenous (Human))
BLA Number
: 125062
351(a)
Octagam (Immune Globulin Intravenous (Human))
BLA Number
: 125062
351(a)
Octagam (Immune Globulin Intravenous (Human))
BLA Number
: 125062
351(a)
Octagam (Immune Globulin Intravenous (Human))
BLA Number
: 125062
351(a)
Octagam (Immune Globulin Intravenous (Human))
BLA Number
: 125062
351(a)
Octagam (Immune Globulin Intravenous (Human))
BLA Number
: 125062
351(a)
Octaplas (Pooled Plasma (Human), Solvent/Detergent Treated)
BLA Number
: 125416
351(a)
Odactra (House Dust Mites (Dermatophagoides farinae and Dermatophagoides pteronyssinus) Allergen Extract)
BLA Number
: 125592
351(a)
Ogivri (trastuzumab-dkst)
BLA Number
: 761074
351(k) Biosimilar
Ogivri (trastuzumab-dkst)
BLA Number
: 761074
351(k) Biosimilar
OMISIRGE (omidubicel-onlv)
BLA Number
: 125738
351(a)
Omlyclo (omalizumab-igec)
BLA Number
: 761399
351(k) Interchangeable
Omlyclo (omalizumab-igec)
BLA Number
: 761399
351(k) Interchangeable
Omlyclo (omalizumab-igec)
BLA Number
: 761399
351(k) Interchangeable
Omnitrope (somatropin)
BLA Number
: 021426
351(a)
Omnitrope (somatropin)
BLA Number
: 021426
351(a)
Omnitrope (somatropin)
BLA Number
: 021426
351(a)
Omnitrope (somatropin)
BLA Number
: 021426
351(a)
Omvoh (mirikizumab-mrkz)
BLA Number
: 761279
351(a)
Omvoh (mirikizumab-mrkz)
BLA Number
: 761279
351(a)
Omvoh (mirikizumab-mrkz)
BLA Number
: 761279
351(a)
Omvoh (mirikizumab-mrkz)
BLA Number
: 761279
351(a)
Omvoh (mirikizumab-mrkz)
BLA Number
: 761279
351(a)
Oncaspar (pegaspargase)
BLA Number
: 103411
351(a)
Ontak (denileukin diftitox)
BLA Number
: 103767
351(a)
Ontruzant (trastuzumab-dttb)
BLA Number
: 761100
351(k) Biosimilar
Ontruzant (trastuzumab-dttb)
BLA Number
: 761100
351(k) Biosimilar
Opdivo (nivolumab)
BLA Number
: 125554
351(a)
Opdivo (nivolumab)
BLA Number
: 125554
351(a)
Opdivo (nivolumab)
BLA Number
: 125554
351(a)
Opdivo (nivolumab)
BLA Number
: 125554
351(a)
Opdivo Qvantig (nivolumab and hyaluronidase-nvhy)
BLA Number
: 761381
351(a)
Opdivo Qvantig (nivolumab and hyaluronidase-nvhy)
BLA Number
: 761381
351(a)
Opdualag (nivolumab and relatlimab-rmbw)
BLA Number
: 761234
351(a)
Opuviz (aflibercept-yszy)
BLA Number
: 761350
351(k) Interchangeable
Oralair (Sweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky Blue Grass Mixed Pollens Allergen Extract)
BLA Number
: 125471
351(a)
Orencia (abatacept)
BLA Number
: 125118
351(a)
Orencia (abatacept)
BLA Number
: 125118
351(a)
Orencia (abatacept)
BLA Number
: 125118
351(a)
Orencia (abatacept)
BLA Number
: 125118
351(a)
Orencia (abatacept)
BLA Number
: 125118
351(a)
Orthoclone OKT3 (muromonab-CD3)
BLA Number
: 103463
351(a)
Osenvelt (denosumab-bmwo)
BLA Number
: 761404
351(k) Interchangeable
Ospomyv (denosumab-dssb)
BLA Number
: 761392
351(k) Interchangeable
Osvyrti (denosumab-desu)
BLA Number
: 761424
351(k) Interchangeable
Otulfi (ustekinumab-aauz)
BLA Number
: 761379
351(k) Interchangeable
Otulfi (ustekinumab-aauz)
BLA Number
: 761379
351(k) Interchangeable
Otulfi (ustekinumab-aauz)
BLA Number
: 761379
351(k) Interchangeable
Otulfi (ustekinumab-aauz)
BLA Number
: 761379
351(k) Interchangeable
Ovidrel (choriogonadotropin alfa)
BLA Number
: 021149
351(a)
Ovidrel (choriogonadotropin alfa)
BLA Number
: 021149
351(a)
Oxervate (cenegermin-bkbj)
BLA Number
: 761094
351(a)
Oziltus (denosumab-mobz)
BLA Number
: 761457
351(k) Interchangeable
Padcev (enfortumab vedotin-ejfv)
BLA Number
: 761137
351(a)
Padcev (enfortumab vedotin-ejfv)
BLA Number
: 761137
351(a)
Palforzia (Peanut (Arachis hypogaea) Allergen Powder-dnfp)
BLA Number
: 125696
351(a)
Palforzia (Peanut (Arachis hypogaea) Allergen Powder-dnfp)
BLA Number
: 125696
351(a)
Palforzia (Peanut (Arachis hypogaea) Allergen Powder-dnfp)
BLA Number
: 125696
351(a)
Palforzia (Peanut (Arachis hypogaea) Allergen Powder-dnfp)
BLA Number
: 125696
351(a)
Palforzia (Peanut (Arachis hypogaea) Allergen Powder-dnfp)
BLA Number
: 125696
351(a)
Palforzia (Peanut (Arachis hypogaea) Allergen Powder-dnfp)
BLA Number
: 125696
351(a)
Palynziq (pegvaliase-pqpz)
BLA Number
: 761079
351(a)
Palynziq (pegvaliase-pqpz)
BLA Number
: 761079
351(a)
Palynziq (pegvaliase-pqpz)
BLA Number
: 761079
351(a)
Pancreaze (pancrelipase)
BLA Number
: 022523
351(a)
Pancreaze (pancrelipase)
BLA Number
: 022523
351(a)
Pancreaze (pancrelipase)
BLA Number
: 022523
351(a)
Pancreaze (pancrelipase)
BLA Number
: 022523
351(a)
Pancreaze (pancrelipase)
BLA Number
: 022523
351(a)
Pancreaze (pancrelipase)
BLA Number
: 022523
351(a)
Panhematin (Hemin for Injection)
BLA Number
: 101246
351(a)
Panzyga (Immune Globulin Intravenous (Human)-ifas)
BLA Number
: 125587
351(a)
Panzyga (Immune Globulin Intravenous (Human)-ifas)
BLA Number
: 125587
351(a)
Panzyga (Immune Globulin Intravenous (Human)-ifas)
BLA Number
: 125587
351(a)
Panzyga (Immune Globulin Intravenous (Human)-ifas)
BLA Number
: 125587
351(a)
Panzyga (Immune Globulin Intravenous (Human)-ifas)
BLA Number
: 125587
351(a)
Panzyga (Immune Globulin Intravenous (Human)-ifas)
BLA Number
: 125587
351(a)
PAPZIMEOS (zopapogene imadenovec-drba)
BLA Number
: 125832
351(a)
Pavblu (aflibercept-ayyh)
BLA Number
: 761298
351(k) Biosimilar
Pavblu (aflibercept-ayyh)
BLA Number
: 761298
351(k) Biosimilar
Pediarix (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine)
BLA Number
: 103907
351(a)
Pedvaxhib (Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate))
BLA Number
: 103237
351(a)
Pegasys (peginterferon alfa-2a)
BLA Number
: 103964
351(a)
Pegasys (peginterferon alfa-2a)
BLA Number
: 103964
351(a)
Pegasys (peginterferon alfa-2a)
BLA Number
: 103964
351(a)
Pegasys (peginterferon alfa-2a)
BLA Number
: 103964
351(a)
Pegasys Copegus Combination Pack (peginterferon alfa-2a and ribavirin)
BLA Number
: 125083
351(a)
Pegasys Copegus Combination Pack (peginterferon alfa-2a and ribavirin)
BLA Number
: 125083
351(a)
Pegasys Copegus Combination Pack (peginterferon alfa-2a and ribavirin)
BLA Number
: 125083
351(a)
Pegintron (peginterferon alfa-2b)
BLA Number
: 103949
351(a)
Pegintron (peginterferon alfa-2b)
BLA Number
: 103949
351(a)
Pegintron (peginterferon alfa-2b)
BLA Number
: 103949
351(a)
Pegintron (peginterferon alfa-2b)
BLA Number
: 103949
351(a)
Pegintron (peginterferon alfa-2b)
BLA Number
: 103949
351(a)
Pegintron (peginterferon alfa-2b)
BLA Number
: 103949
351(a)
Pegintron (peginterferon alfa-2b)
BLA Number
: 103949
351(a)
Pegintron (peginterferon alfa-2b)
BLA Number
: 103949
351(a)
PegIntron/ Rebetol Combo Pack (peginterferon alfa-2b and ribavirin)
BLA Number
: 125196
351(a)
PegIntron/ Rebetol Combo Pack (peginterferon alfa-2b and ribavirin)
BLA Number
: 125196
351(a)
PegIntron/ Rebetol Combo Pack (peginterferon alfa-2b and ribavirin)
BLA Number
: 125196
351(a)
PegIntron/ Rebetol Combo Pack (peginterferon alfa-2b and ribavirin)
BLA Number
: 125196
351(a)
PENBRAYA (Meningococcal Groups A, B, C, W, and Y Vaccine)
BLA Number
: 125770
351(a)
PENMENVY (Meningococcal Groups A, B, C, W and Y Vaccine)
BLA Number
: 125819
351(a)
Pentacel (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine)
BLA Number
: 125145
351(a)
Pergonal (menotropins)
BLA Number
: 017646
351(a)
Pergonal (menotropins)
BLA Number
: 017646
351(a)
Perjeta (pertuzumab)
BLA Number
: 125409
351(a)
Pertzye (pancrelipase)
BLA Number
: 022175
351(a)
Pertzye (pancrelipase)
BLA Number
: 022175
351(a)
Pertzye (pancrelipase)
BLA Number
: 022175
351(a)
Pertzye (pancrelipase)
BLA Number
: 022175
351(a)
Pharmalgen (Venoms, Honey Bee Venom)
BLA Number
: 103969
351(a)
Pharmalgen (Venoms, Honey Bee Venom)
BLA Number
: 103969
351(a)
Pharmalgen (Venoms, Mixed Vespid Venom Protein)
BLA Number
: 103970
351(a)
Pharmalgen (Venoms, Mixed Vespid Venom Protein)
BLA Number
: 103970
351(a)
Pharmalgen (Venoms, Wasp Venom Protein)
BLA Number
: 103971
351(a)
Pharmalgen (Venoms, Wasp Venom Protein)
BLA Number
: 103971
351(a)
Pharmalgen (Venoms, White Faced Hornet Venom Protein)
BLA Number
: 103972
351(a)
Pharmalgen (Venoms, White Faced Hornet Venom Protein)
BLA Number
: 103972
351(a)
Pharmalgen (Venoms, Yellow Hornet Venom Protein)
BLA Number
: 103973
351(a)
Pharmalgen (Venoms, Yellow Hornet Venom Protein)
BLA Number
: 103973
351(a)
Pharmalgen (Venoms, Yellow Jacket Venom Protein)
BLA Number
: 103974
351(a)
Pharmalgen (Venoms, Yellow Jacket Venom Protein)
BLA Number
: 103974
351(a)
Phesgo (pertuzumab, trastuzumab, and hyaluronidase-zzxf)
BLA Number
: 761170
351(a)
Phesgo (pertuzumab, trastuzumab, and hyaluronidase-zzxf)
BLA Number
: 761170
351(a)
Piasky (crovalimab-akkz)
BLA Number
: 761388
351(a)
Plasmanate (Plasma Protein Fraction (Human))
BLA Number
: 101140
351(a)
Plasmanate (Plasma Protein Fraction (Human))
BLA Number
: 101140
351(a)
Plasmanate (Plasma Protein Fraction (Human))
BLA Number
: 101140
351(a)
Plegridy (peginterferon beta-1a)
BLA Number
: 125499
351(a)
Plegridy (peginterferon beta-1a)
BLA Number
: 125499
351(a)
Plegridy (peginterferon beta-1a)
BLA Number
: 125499
351(a)
Plegridy (peginterferon beta-1a)
BLA Number
: 125499
351(a)
Plegridy (peginterferon beta-1a)
BLA Number
: 125499
351(a)
Plegridy (peginterferon beta-1a)
BLA Number
: 125499
351(a)
Pneumovax 23 (Pneumococcal Vaccine, Polyvalent)
BLA Number
: 101094
351(a)
Pneumovax 23 (Pneumococcal Vaccine, Polyvalent)
BLA Number
: 101094
351(a)
Poherdy (pertuzumab-dpzb)
BLA Number
: 761450
351(k) Interchangeable
Poliovax (Poliovirus Vaccine Inactivated (Human Diploid Cell))
BLA Number
: 103940
351(a)
Poliovax (Poliovirus Vaccine Inactivated (Human Diploid Cell))
BLA Number
: 103940
351(a)
Polivy (polatuzumab vedotin-piiq)
BLA Number
: 761121
351(a)
Polivy (polatuzumab vedotin-piiq)
BLA Number
: 761121
351(a)
Pombiliti (cipaglucosidase alfa-atga)
BLA Number
: 761204
351(a)
Ponlimsi (denosumab-adet)
BLA Number
: 761385
351(k) Interchangeable
Portrazza (necitumumab)
BLA Number
: 125547
351(a)
Poteligeo (mogamulizumab-kpkc)
BLA Number
: 761051
351(a)
Praluent (alirocumab)
BLA Number
: 125559
351(a)
Praluent (alirocumab)
BLA Number
: 125559
351(a)
Praluent (alirocumab)
BLA Number
: 125559
351(a)
Praluent (alirocumab)
BLA Number
: 125559
351(a)
Praxbind (idarucizumab)
BLA Number
: 761025
351(a)
Pre-Pen (benzylpenicilloyl polylysine)
BLA Number
: 050114
351(a)
Pregnyl (chorionic gonadotropin)
BLA Number
: 017692
351(a)
Prehevbrio (Hepatitis B Vaccine (Recombinant))
BLA Number
: 125737
351(a)
prevnar (Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein))
BLA Number
: 103905
351(a)
Prevnar 13 (Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein))
BLA Number
: 125324
351(a)
Prevnar 20 (Pneumococcal 20-valent Conjugate Vaccine)
BLA Number
: 125731
351(a)
PRIORIX (Measles, Mumps and Rubella Vaccine Live)
BLA Number
: 125748
351(a)
Privigen (Immune Globulin Intravenous (Human), 10% Liquid)
BLA Number
: 125201
351(a)
Privigen (Immune Globulin Intravenous (Human), 10% Liquid)
BLA Number
: 125201
351(a)
Privigen (Immune Globulin Intravenous (Human), 10% Liquid)
BLA Number
: 125201
351(a)
Privigen (Immune Globulin Intravenous (Human), 10% Liquid)
BLA Number
: 125201
351(a)
Privigen (Immune Globulin Intravenous (Human), 10% Liquid)
BLA Number
: 125201
351(a)
Procrit (epoetin alfa)
BLA Number
: 103234
351(a)
Profilnine, Profilnine Hp, Profilnine Ht, Profilnine Sd (Factor IX Complex)
BLA Number
: 102476
351(a)
Profilnine, Profilnine Hp, Profilnine Ht, Profilnine Sd (Factor IX Complex)
BLA Number
: 102476
351(a)
Profilnine, Profilnine Hp, Profilnine Ht, Profilnine Sd (Factor IX Complex)
BLA Number
: 102476
351(a)
prolastin,prolastin-c,prolastin-c liquid (Alpha-1-Proteinase Inhibitor (Human))
BLA Number
: 103174
351(a)
prolastin,prolastin-c,prolastin-c liquid (Alpha-1-Proteinase Inhibitor (Human))
BLA Number
: 103174
351(a)
prolastin,prolastin-c,prolastin-c liquid (Alpha-1-Proteinase Inhibitor (Human))
BLA Number
: 103174
351(a)
prolastin,prolastin-c,prolastin-c liquid (Alpha-1-Proteinase Inhibitor (Human))
BLA Number
: 103174
351(a)
prolastin,prolastin-c,prolastin-c liquid (Alpha-1-Proteinase Inhibitor (Human))
BLA Number
: 103174
351(a)
Proleukin (aldesleukin)
BLA Number
: 103293
351(a)
Prolia (denosumab)
BLA Number
: 125320
351(a)
Prolia (denosumab)
BLA Number
: 125320
351(a)
Proplex-T; Bebulin (Factor IX Complex)
BLA Number
: 103112
351(a)
Proquad (Measles, Mumps, Rubella and Varicella Virus Vaccine Live)
BLA Number
: 125108
351(a)
Proquad (Measles, Mumps, Rubella and Varicella Virus Vaccine Live)
BLA Number
: 125108
351(a)
ProstaScint (capromab pendetide)
BLA Number
: 103608
351(a)
Provenge (sipuleucel-T)
BLA Number
: 125197
351(a)
Pulmolite (kit for the preparation of technetium Tc-99m albumin aggregated)
BLA Number
: 017776
351(a)
Pulmotech MAA (kit for the preparation of technetium Tc-99m albumin aggregated)
BLA Number
: 210089
351(a)
Pulmozyme (dornase alfa)
BLA Number
: 103532
351(a)
Pyzchiva (ustekinumab-ttwe)
BLA Number
: 761373
351(k) Interchangeable
Pyzchiva (ustekinumab-ttwe)
BLA Number
: 761373
351(k) Interchangeable
Pyzchiva (ustekinumab-ttwe)
BLA Number
: 761373
351(k) Interchangeable
Pyzchiva (ustekinumab-ttwe)
BLA Number
: 761373
351(k) Interchangeable
Pyzchiva (ustekinumab-ttwe)
BLA Number
: 761373
351(k) Interchangeable
Pyzchiva (ustekinumab-ttwe)
BLA Number
: 761425
351(k) Interchangeable
QIVIGY (Immune Globulin Intravenous, Human-kthm, 10% Solution)
BLA Number
: 125822
351(a)
QIVIGY (Immune Globulin Intravenous, Human-kthm, 10% Solution)
BLA Number
: 125822
351(a)
Quadracel (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine)
BLA Number
: 125525
351(a)
Quadracel (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine)
BLA Number
: 125525
351(a)
Qwo (collagenase clostridium histolyticum-aaes)
BLA Number
: 761146
351(a)
Qwo (collagenase clostridium histolyticum-aaes)
BLA Number
: 761146
351(a)
Rabavert (Rabies Vaccine)
BLA Number
: 103334
351(a)
Ragwitek (Short Ragweed Pollen Allergen Extract)
BLA Number
: 125478
351(a)
Raplixa (Fibrin Sealant (Human))
BLA Number
: 125523
351(a)
Raplixa (Fibrin Sealant (Human))
BLA Number
: 125523
351(a)
Raplixa (Fibrin Sealant (Human))
BLA Number
: 125523
351(a)
Raptiva (efalizumab)
BLA Number
: 125075
351(a)
Rebif (interferon beta-1a)
BLA Number
: 103780
351(a)
Rebif (interferon beta-1a)
BLA Number
: 103780
351(a)
Rebif (interferon beta-1a)
BLA Number
: 103780
351(a)
Rebif (interferon beta-1a)
BLA Number
: 103780
351(a)
Rebif (interferon beta-1a)
BLA Number
: 103780
351(a)
Rebif (interferon beta-1a)
BLA Number
: 103780
351(a)
Rebinyn (Coagulation Factor IX (Recombinant), GlycoPEGylated)
BLA Number
: 125611
351(a)
Rebinyn (Coagulation Factor IX (Recombinant), GlycoPEGylated)
BLA Number
: 125611
351(a)
Rebinyn (Coagulation Factor IX (Recombinant), GlycoPEGylated)
BLA Number
: 125611
351(a)
Rebinyn (Coagulation Factor IX (Recombinant), GlycoPEGylated)
BLA Number
: 125611
351(a)
Reblozyl (luspatercept-aamt)
BLA Number
: 761136
351(a)
Reblozyl (luspatercept-aamt)
BLA Number
: 761136
351(a)
Rebyota (fecal microbiota, live-jslm)
BLA Number
: 125739
351(a)
Recombivax, Recombivax Hb (Hepatitis B Vaccine (Recombinant))
BLA Number
: 101066
351(a)
Recombivax, Recombivax Hb (Hepatitis B Vaccine (Recombinant))
BLA Number
: 101066
351(a)
Recombivax, Recombivax Hb (Hepatitis B Vaccine (Recombinant))
BLA Number
: 101066
351(a)
Recothrom (Thrombin topical (Recombinant))
BLA Number
: 125248
351(a)
Recothrom (Thrombin topical (Recombinant))
BLA Number
: 125248
351(a)
Refacto (Antihemophilic Factor (Recombinant))
BLA Number
: 103779
351(a)
Refacto (Antihemophilic Factor (Recombinant))
BLA Number
: 103779
351(a)
Refacto (Antihemophilic Factor (Recombinant))
BLA Number
: 103779
351(a)
Refacto (Antihemophilic Factor (Recombinant))
BLA Number
: 103779
351(a)
regenecyte (HPC, Cord Blood)
BLA Number
: 125764
351(a)
Regranex (becaplermin)
BLA Number
: 103691
351(a)
Releuko (filgrastim-ayow)
BLA Number
: 761082
351(k) Biosimilar
Releuko (filgrastim-ayow)
BLA Number
: 761082
351(k) Biosimilar
Releuko (filgrastim-ayow)
BLA Number
: 761082
351(k) Biosimilar
Releuko (filgrastim-ayow)
BLA Number
: 761082
351(k) Biosimilar
Remicade (infliximab)
BLA Number
: 103772
351(a)
Renflexis (infliximab-abda)
BLA Number
: 761054
351(k) Biosimilar
Reopro (abciximab)
BLA Number
: 103575
351(a)
Repatha (evolocumab)
BLA Number
: 125522
351(a)
Repatha (evolocumab)
BLA Number
: 125522
351(a)
Repatha (evolocumab)
BLA Number
: 125522
351(a)
Repronex (menotropins)
BLA Number
: 021047
351(a)
Repronex (menotropins)
BLA Number
: 021047
351(a)
Retacrit (epoetin alfa-epbx)
BLA Number
: 125545
351(k) Biosimilar
Retacrit (epoetin alfa-epbx)
BLA Number
: 125545
351(k) Biosimilar
Retacrit (epoetin alfa-epbx)
BLA Number
: 125545
351(k) Biosimilar
Retacrit (epoetin alfa-epbx)
BLA Number
: 125545
351(k) Biosimilar
Retacrit (epoetin alfa-epbx)
BLA Number
: 125545
351(k) Biosimilar
Retacrit (epoetin alfa-epbx)
BLA Number
: 125545
351(k) Biosimilar
Retacrit (epoetin alfa-epbx)
BLA Number
: 125545
351(k) Biosimilar
Retavase (reteplase)
BLA Number
: 103786
351(a)
Rethymic (allogeneic processed thymus tissue-agdc)
BLA Number
: 125685
351(a)
Revcovi (elapegademase-lvlr)
BLA Number
: 761092
351(a)
Rezvoglar (insulin glargine-aglr)
BLA Number
: 761215
351(k) Interchangeable
Rhophylac (Rho(D) Immune Globulin Intravenous (Human))
BLA Number
: 125070
351(a)
Rhophylac (Rho(D) Immune Globulin Intravenous (Human))
BLA Number
: 125070
351(a)
Riabni (rituximab-arrx)
BLA Number
: 761140
351(k) Biosimilar
Riabni (rituximab-arrx)
BLA Number
: 761140
351(k) Biosimilar
Riastap (Fibrinogen Concentrate (Human))
BLA Number
: 125317
351(a)
Rituxan (rituximab)
BLA Number
: 103705
351(a)
Rituxan (rituximab)
BLA Number
: 103737
351(a)
Rituxan (rituximab)
BLA Number
: 103737
351(a)
Rituxan (rituximab)
BLA Number
: 103705
351(a)
Rituxan Hycela (rituximab and hyaluronidase human)
BLA Number
: 761064
351(a)
Rituxan Hycela (rituximab and hyaluronidase human)
BLA Number
: 761064
351(a)
Rixubis (Coagulation Factor IX (Recombinant))
BLA Number
: 125446
351(a)
Rixubis (Coagulation Factor IX (Recombinant))
BLA Number
: 125446
351(a)
Rixubis (Coagulation Factor IX (Recombinant))
BLA Number
: 125446
351(a)
Rixubis (Coagulation Factor IX (Recombinant))
BLA Number
: 125446
351(a)
Rixubis (Coagulation Factor IX (Recombinant))
BLA Number
: 125446
351(a)
Roctavian (valoctocogene roxaparvovec-rvox)
BLA Number
: 125720
351(a)
Roferon-A (interferon alfa-2a)
BLA Number
: 103145
351(a)
Rolvedon (eflapegrastim-xnst)
BLA Number
: 761148
351(a)
Rotarix (Rotavirus Vaccine, Live, Oral)
BLA Number
: 125265
351(a)
Rotarix (Rotavirus Vaccine, Live, Oral)
BLA Number
: 125265
351(a)
Rotarix (Rotavirus Vaccine, Live, Oral)
BLA Number
: 125265
351(a)
Rotateq (Rotavirus Vaccine, Live, Oral, Pentavalent)
BLA Number
: 125122
351(a)
Rotateq (Rotavirus Vaccine, Live, Oral, Pentavalent)
BLA Number
: 125122
351(a)
Ruconest (C1 Esterase Inhibitor (Recombinant))
BLA Number
: 125495
351(a)
Ruxience (rituximab-pvvr)
BLA Number
: 761103
351(k) Biosimilar
Ruxience (rituximab-pvvr)
BLA Number
: 761103
351(k) Biosimilar
Rybrevant (amivantamab-vmjw)
BLA Number
: 761210
351(a)
Rybrevant Faspro (amivantamab and hyaluronidase-lpuj)
BLA Number
: 761484
351(a)
Rybrevant Faspro (amivantamab and hyaluronidase-lpuj)
BLA Number
: 761484
351(a)
Rybrevant Faspro (amivantamab and hyaluronidase-lpuj)
BLA Number
: 761484
351(a)
Rybrevant Faspro (amivantamab and hyaluronidase-lpuj)
BLA Number
: 761484
351(a)
Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn)
BLA Number
: 761179
351(a)
ryoncil (remestemcel-L-rknd)
BLA Number
: 125706
351(a)
Ryplazim (plasminogen, human-tvmh)
BLA Number
: 125659
351(a)
Rystiggo (rozanolixizumab-noli)
BLA Number
: 761286
351(a)
Rystiggo (rozanolixizumab-noli)
BLA Number
: 761286
351(a)
Rystiggo (rozanolixizumab-noli)
BLA Number
: 761286
351(a)
Rystiggo (rozanolixizumab-noli)
BLA Number
: 761286
351(a)
Ryzneuta (efbemalenograstim alfa-vuxw)
BLA Number
: 761134
351(a)
Ryzodeg 70/30 (insulin degludec and insulin aspart)
BLA Number
: 203313
351(a)
Saizen (somatropin)
BLA Number
: 019764
351(a)
Saizen (somatropin)
BLA Number
: 019764
351(a)
Saizen (somatropin)
BLA Number
: 019764
351(a)
Saizen (somatropin)
BLA Number
: 019764
351(a)
Santyl (collagenase)
BLA Number
: 101995
351(a)
Saphnelo (anifrolumab-fnia)
BLA Number
: 761123
351(a)
Sarclisa (isatuximab-irfc)
BLA Number
: 761113
351(a)
Sarclisa (isatuximab-irfc)
BLA Number
: 761113
351(a)
Selarsdi (ustekinumab-aekn)
BLA Number
: 761343
351(k) Interchangeable
Selarsdi (ustekinumab-aekn)
BLA Number
: 761343
351(k) Interchangeable
Selarsdi (ustekinumab-aekn)
BLA Number
: 761343
351(k) Interchangeable
Selarsdi (ustekinumab-aekn)
BLA Number
: 761343
351(k) Interchangeable
Semglee (insulin glargine-yfgn)
BLA Number
: 761201
351(k) Interchangeable
Semglee (insulin glargine-yfgn)
BLA Number
: 761201
351(k) Interchangeable
Semglee (insulin glargine)
BLA Number
: 210605
351(a)
Semglee (insulin glargine)
BLA Number
: 210605
351(a)
Serostim (somatropin)
BLA Number
: 020604
351(a)
Serostim (somatropin)
BLA Number
: 020604
351(a)
Serostim (somatropin)
BLA Number
: 020604
351(a)
Serostim (somatropin)
BLA Number
: 020604
351(a)
Sevenfact (coagulation factor VIIa (recombinant)-jncw)
BLA Number
: 125641
351(a)
Sevenfact (coagulation factor VIIa (recombinant)-jncw)
BLA Number
: 125641
351(a)
Sevenfact (coagulation factor VIIa (recombinant)-jncw)
BLA Number
: 125641
351(a)
Shingrix (Zoster Vaccine Recombinant, Adjuvanted)
BLA Number
: 125614
351(a)
Shingrix (Zoster Vaccine Recombinant, Adjuvanted)
BLA Number
: 125614
351(a)
Shingrix (Zoster Vaccine Recombinant, Adjuvanted)
BLA Number
: 125614
351(a)
Siliq (brodalumab)
BLA Number
: 761032
351(a)
Simlandi (adalimumab-ryvk)
BLA Number
: 761299
351(k) Interchangeable
Simlandi (adalimumab-ryvk)
BLA Number
: 761299
351(k) Interchangeable
Simlandi (adalimumab-ryvk)
BLA Number
: 761299
351(k) Interchangeable
Simlandi (adalimumab-ryvk)
BLA Number
: 761299
351(k) Interchangeable
Simlandi (adalimumab-ryvk)
BLA Number
: 761299
351(k) Interchangeable
Simponi (golimumab)
BLA Number
: 125289
351(a)
Simponi (golimumab)
BLA Number
: 125289
351(a)
Simponi (golimumab)
BLA Number
: 125289
351(a)
Simponi (golimumab)
BLA Number
: 125289
351(a)
Simponi Aria (golimumab)
BLA Number
: 125433
351(a)
Simulect (basiliximab)
BLA Number
: 103764
351(a)
Simulect (basiliximab)
BLA Number
: 103764
351(a)
Skyrizi (risankizumab-rzaa)
BLA Number
: 761105
351(a)
Skyrizi (risankizumab-rzaa)
BLA Number
: 761105
351(a)
Skyrizi (risankizumab-rzaa)
BLA Number
: 761105
351(a)
Skyrizi (risankizumab-rzaa)
BLA Number
: 761262
351(a)
Skyrizi (risankizumab-rzaa)
BLA Number
: 761105
351(a)
Skyrizi (risankizumab-rzaa)
BLA Number
: 761105
351(a)
Skyrizi (risankizumab-rzaa)
BLA Number
: 761105
351(a)
Skyrizi (risankizumab-rzaa)
BLA Number
: 761105
351(a)
Skysona (elivaldogene autotemcel)
BLA Number
: 125755
351(a)
Skytrofa (lonapegsomatropin-tcgd)
BLA Number
: 761177
351(a)
Skytrofa (lonapegsomatropin-tcgd)
BLA Number
: 761177
351(a)
Skytrofa (lonapegsomatropin-tcgd)
BLA Number
: 761177
351(a)
Skytrofa (lonapegsomatropin-tcgd)
BLA Number
: 761177
351(a)
Skytrofa (lonapegsomatropin-tcgd)
BLA Number
: 761177
351(a)
Skytrofa (lonapegsomatropin-tcgd)
BLA Number
: 761177
351(a)
Skytrofa (lonapegsomatropin-tcgd)
BLA Number
: 761177
351(a)
Skytrofa (lonapegsomatropin-tcgd)
BLA Number
: 761177
351(a)
Skytrofa (lonapegsomatropin-tcgd)
BLA Number
: 761177
351(a)
Skytrofa (lonapegsomatropin-tcgd)
BLA Number
: 761177
351(a)
Skytrofa (lonapegsomatropin-tcgd)
BLA Number
: 761177
351(a)
Skytrofa (lonapegsomatropin-tcgd)
BLA Number
: 761177
351(a)
Skytrofa (lonapegsomatropin-tcgd)
BLA Number
: 761177
351(a)
Skytrofa (lonapegsomatropin-tcgd)
BLA Number
: 761177
351(a)
Sogroya (somapacitan-beco)
BLA Number
: 761156
351(a)
Sogroya (somapacitan-beco)
BLA Number
: 761156
351(a)
Sogroya (somapacitan-beco)
BLA Number
: 761156
351(a)
Soliqua 100/33 (insulin glargine and lixisenatide)
BLA Number
: 208673
351(a)
Soliris (eculizumab)
BLA Number
: 125166
351(a)
Somavert (pegvisomant)
BLA Number
: 021106
351(a)
Somavert (pegvisomant)
BLA Number
: 021106
351(a)
Somavert (pegvisomant)
BLA Number
: 021106
351(a)
Somavert (pegvisomant)
BLA Number
: 021106
351(a)
Somavert (pegvisomant)
BLA Number
: 021106
351(a)
Spevigo (spesolimab-sbzo)
BLA Number
: 761244
351(a)
Spevigo (spesolimab-sbzo)
BLA Number
: 761244
351(a)
Spevigo (spesolimab-sbzo)
BLA Number
: 761244
351(a)
Spherusol (Coccidioides immitis Spherule-Derived Skin Test Antigen)
BLA Number
: 125354
351(a)
Spikevax (COVID-19 Vaccine, mRNA)
BLA Number
: 125752
351(a)
Spikevax (COVID-19 Vaccine, mRNA)
BLA Number
: 125752
351(a)
Spikevax (COVID-19 Vaccine, mRNA)
BLA Number
: 125752
351(a)
Spikevax (COVID-19 Vaccine, mRNA)
BLA Number
: 125752
351(a)
Spikevax (COVID-19 Vaccine, mRNA)
BLA Number
: 125752
351(a)
Starjemza (ustekinumab-hmny)
BLA Number
: 761419
351(k) Interchangeable
Starjemza (ustekinumab-hmny)
BLA Number
: 761419
351(k) Interchangeable
Starjemza (ustekinumab-hmny)
BLA Number
: 761419
351(k) Interchangeable
Starjemza (ustekinumab-hmny)
BLA Number
: 761419
351(k) Interchangeable
Stelara (ustekinumab)
BLA Number
: 125261
351(a)
Stelara (ustekinumab)
BLA Number
: 125261
351(a)
Stelara (ustekinumab)
BLA Number
: 125261
351(a)
Stelara (ustekinumab)
BLA Number
: 125261
351(a)
Stelara (ustekinumab)
BLA Number
: 761044
351(a)
Steqeyma (ustekinumab-stba)
BLA Number
: 761338
351(k) Interchangeable
Steqeyma (ustekinumab-stba)
BLA Number
: 761338
351(k) Interchangeable
Steqeyma (ustekinumab-stba)
BLA Number
: 761338
351(k) Interchangeable
Steqeyma (ustekinumab-stba)
BLA Number
: 761338
351(k) Interchangeable
Stimufend (pegfilgrastim-fpgk)
BLA Number
: 761173
351(k) Biosimilar
Stoboclo (denosumab-bmwo)
BLA Number
: 761404
351(k) Interchangeable
StrataGraft (Allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen-dsat)
BLA Number
: 125730
351(a)
Strensiq (asfotase alfa)
BLA Number
: 125513
351(a)
Strensiq (asfotase alfa)
BLA Number
: 125513
351(a)
Strensiq (asfotase alfa)
BLA Number
: 125513
351(a)
Strensiq (asfotase alfa)
BLA Number
: 125513
351(a)
Sucraid (sacrosidase)
BLA Number
: 020772
351(a)
Sucraid (sacrosidase)
BLA Number
: 020772
351(a)
Survanta (beractant)
BLA Number
: 020032
351(a)
Survanta (beractant)
BLA Number
: 020032
351(a)
Susvimo (ranibizumab)
BLA Number
: 761197
351(a)
Sylatron (peginterferon alfa-2b)
BLA Number
: 103949
351(a)
Sylatron (peginterferon alfa-2b)
BLA Number
: 103949
351(a)
Sylatron (peginterferon alfa-2b)
BLA Number
: 103949
351(a)
Sylvant (siltuximab)
BLA Number
: 125496
351(a)
Sylvant (siltuximab)
BLA Number
: 125496
351(a)
symvess (acellular tissue engineered vessel-tyod)
BLA Number
: 125812
351(a)
Synagis (palivizumab)
BLA Number
: 103770
351(a)
Synagis (palivizumab)
BLA Number
: 103770
351(a)
Synagis (palivizumab)
BLA Number
: 103770
351(a)
Synagis (palivizumab)
BLA Number
: 103770
351(a)
T.R.U.E. Test (Thin-Layer Rapid Use Epicutaneous Patch Test)
BLA Number
: 103738
351(a)
Tachosil (Fibrin Sealant Patch)
BLA Number
: 125351
351(a)
Tachosil (Fibrin Sealant Patch)
BLA Number
: 125351
351(a)
Tachosil (Fibrin Sealant Patch)
BLA Number
: 125351
351(a)
Takhzyro (lanadelumab-flyo)
BLA Number
: 761090
351(a)
Takhzyro (lanadelumab-flyo)
BLA Number
: 761090
351(a)
Takhzyro (lanadelumab-flyo)
BLA Number
: 761090
351(a)
Taltz (ixekizumab)
BLA Number
: 125521
351(a)
Taltz (ixekizumab)
BLA Number
: 125521
351(a)
Taltz (ixekizumab)
BLA Number
: 125521
351(a)
Taltz (ixekizumab)
BLA Number
: 125521
351(a)
Talvey (talquetamab-tgvs)
BLA Number
: 761342
351(a)
Talvey (talquetamab-tgvs)
BLA Number
: 761342
351(a)
Tanzeum (albiglutide)
BLA Number
: 125431
351(a)
Tanzeum (albiglutide)
BLA Number
: 125431
351(a)
Tdvax (Tetanus and Diphtheria Toxoids Adsorbed)
BLA Number
: 101322
351(a)
Tecartus (Brexucabtagene Autoleucel)
BLA Number
: 125703
351(a)
tecelra (afamitresgene autoleucel)
BLA Number
: 125789
351(a)
Tecentriq (atezolizumab)
BLA Number
: 761034
351(a)
Tecentriq (atezolizumab)
BLA Number
: 761034
351(a)
Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs)
BLA Number
: 761347
351(a)
Tecvayli (teclistamab-cqyv)
BLA Number
: 761291
351(a)
Tecvayli (teclistamab-cqyv)
BLA Number
: 761291
351(a)
Tenivac (Tetanus and Diphtheria Toxoids Adsorbed)
BLA Number
: 103171
351(a)
Tenivac (Tetanus and Diphtheria Toxoids Adsorbed)
BLA Number
: 103171
351(a)
Tepezza (teprotumumab-trbw)
BLA Number
: 761143
351(a)
Tevimbra (tislelizumab-jsgr)
BLA Number
: 761232
351(a)
Tezspire (tezepelumab-ekko)
BLA Number
: 761224
351(a)
Tezspire (tezepelumab-ekko)
BLA Number
: 761224
351(a)
Tezspire (tezepelumab-ekko)
BLA Number
: 761224
351(a)
TheraCys (BCG Live)
BLA Number
: 103943
351(a)
Thrombate Iii (Antithrombin III (Human))
BLA Number
: 103196
351(a)
Thrombin-Jmi, Thrombocoll (Thrombin, Topical (Bovine))
BLA Number
: 102865
351(a)
Thrombin-Jmi, Thrombocoll (Thrombin, Topical (Bovine))
BLA Number
: 102865
351(a)
Thrombin-Jmi, Thrombocoll (Thrombin, Topical (Bovine))
BLA Number
: 102865
351(a)
Thrombin-Jmi, Thrombocoll (Thrombin, Topical (Bovine))
BLA Number
: 102865
351(a)
Thymoglobulin (Anti-thymocyte Globulin (Rabbit))
BLA Number
: 103869
351(a)
Thyrogen (thyrotropin alfa)
BLA Number
: 020898
351(a)
Tice Bcg (BCG Live)
BLA Number
: 102821
351(a)
Ticovac (Tick-Borne Encephalitis Vaccine)
BLA Number
: 125740
351(a)
Ticovac (Tick-Borne Encephalitis Vaccine)
BLA Number
: 125740
351(a)
Tisseel (Fibrin Sealant (Tisseel))
BLA Number
: 103980
351(a)
Tisseel (Fibrin Sealant (Tisseel))
BLA Number
: 103980
351(a)
Tivdak (tisotumab vedotin-tftv)
BLA Number
: 761208
351(a)
TNKase (tenecteplase)
BLA Number
: 103909
351(a)
TNKase (tenecteplase)
BLA Number
: 103909
351(a)
Tofidence (tocilizumab-bavi)
BLA Number
: 761354
351(k) Biosimilar
Tofidence (tocilizumab-bavi)
BLA Number
: 761354
351(k) Biosimilar
Tofidence (tocilizumab-bavi)
BLA Number
: 761354
351(k) Biosimilar
Toujeo (insulin glargine)
BLA Number
: 206538
351(a)
Toujeo (insulin glargine)
BLA Number
: 206538
351(a)
Trasylol (aprotinin)
BLA Number
: 020304
351(a)
Trasylol (aprotinin)
BLA Number
: 020304
351(a)
Trazimera (trastuzumab-qyyp)
BLA Number
: 761081
351(k) Biosimilar
Trazimera (trastuzumab-qyyp)
BLA Number
: 761081
351(k) Biosimilar
Tremfya (guselkumab)
BLA Number
: 761061
351(a)
Tremfya (guselkumab)
BLA Number
: 761061
351(a)
Tremfya (guselkumab)
BLA Number
: 761061
351(a)
Tremfya (guselkumab)
BLA Number
: 761061
351(a)
Tremfya (guselkumab)
BLA Number
: 761061
351(a)
Tremfya (guselkumab)
BLA Number
: 761061
351(a)
Tresiba (insulin degludec)
BLA Number
: 203314
351(a)
Tresiba (insulin degludec)
BLA Number
: 203314
351(a)
Tresiba (insulin degludec)
BLA Number
: 203314
351(a)
Tretten (Coagulation Factor XIII A-Subunit (Recombinant))
BLA Number
: 125398
351(a)
Tripedia (Diphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine Adsorbed)
BLA Number
: 103922
351(a)
Trodelvy (sacituzumab govitecan-hziy)
BLA Number
: 761115
351(a)
Trogarzo (ibalizumab-uiyk)
BLA Number
: 761065
351(a)
Trulicity (dulaglutide)
BLA Number
: 125469
351(a)
Trulicity (dulaglutide)
BLA Number
: 125469
351(a)
Trulicity (dulaglutide)
BLA Number
: 125469
351(a)
Trulicity (dulaglutide)
BLA Number
: 125469
351(a)
Trulicity (dulaglutide)
BLA Number
: 125469
351(a)
Trulicity (dulaglutide)
BLA Number
: 125469
351(a)
Trumenba (Meningococcal Group B Vaccine)
BLA Number
: 125549
351(a)
Truxima (rituximab-abbs)
BLA Number
: 761088
351(k) Biosimilar
Truxima (rituximab-abbs)
BLA Number
: 761088
351(k) Biosimilar
Tubersol (Tuberculin, Purified Protein Derivative)
BLA Number
: 103941
351(a)
Twinrix (Hepatitis A & Hepatitis B (Recombinant) Vaccine)
BLA Number
: 103850
351(a)
Tyenne (tocilizumab-aazg)
BLA Number
: 761275
351(k) Biosimilar
Tyenne (tocilizumab-aazg)
BLA Number
: 761275
351(k) Biosimilar
Tyenne (tocilizumab-aazg)
BLA Number
: 761275
351(k) Biosimilar
Tyenne (tocilizumab-aazg)
BLA Number
: 761449
351(k) Biosimilar
Tyenne (tocilizumab-aazg)
BLA Number
: 761449
351(k) Biosimilar
Typhim Vi (Typhoid Vi Polysaccharide Vaccine)
BLA Number
: 103936
351(a)
Typhim Vi (Typhoid Vi Polysaccharide Vaccine)
BLA Number
: 103936
351(a)
Tyruko (natalizumab-sztn)
BLA Number
: 761322
351(k) Biosimilar
Tysabri (natalizumab)
BLA Number
: 125104
351(a)
Tzield (teplizumab-mzwv)
BLA Number
: 761183
351(a)
Udenyca (pegfilgrastim-cbqv)
BLA Number
: 761039
351(k) Biosimilar
Udenyca (pegfilgrastim-cbqv)
BLA Number
: 761039
351(k) Biosimilar
Udenyca Onbody (pegfilgrastim-cbqv)
BLA Number
: 761039
351(k) Biosimilar
Ultomiris (ravulizumab-cwvz)
BLA Number
: 761108
351(a)
Ultomiris (ravulizumab-cwvz)
BLA Number
: 761108
351(a)
Ultomiris (ravulizumab-cwvz)
BLA Number
: 761108
351(a)
Ultomiris (ravulizumab-cwvz)
BLA Number
: 761108
351(a)
Unituxin (dinutuximab)
BLA Number
: 125516
351(a)
Unloxcyt (cosibelimab-ipdl)
BLA Number
: 761297
351(a)
Uplizna (inebilizumab-cdon)
BLA Number
: 761142
351(a)
Vabysmo (faricimab-svoa)
BLA Number
: 761235
351(a)
Vabysmo (faricimab-svoa)
BLA Number
: 761235
351(a)
Vaqta (Hepatitis A Vaccine Inactivated)
BLA Number
: 103606
351(a)
Vaqta (Hepatitis A Vaccine Inactivated)
BLA Number
: 103606
351(a)
Vaqta (Hepatitis A Vaccine Inactivated)
BLA Number
: 103606
351(a)
Vaqta (Hepatitis A Vaccine Inactivated)
BLA Number
: 103606
351(a)
Varivax (Varicella Virus Vaccine Live)
BLA Number
: 103552
351(a)
Varivax (Varicella Virus Vaccine Live)
BLA Number
: 103552
351(a)
Varizig (Varicella Zoster Immune Globulin (Human))
BLA Number
: 125430
351(a)
Varizig (Varicella Zoster Immune Globulin (Human))
BLA Number
: 125430
351(a)
Vaxchora (Cholera Vaccine, Live, Oral)
BLA Number
: 125597
351(a)
Vaxchora (Cholera Vaccine, Live, Oral)
BLA Number
: 125597
351(a)
Vaxchora (Cholera Vaccine, Live, Oral)
BLA Number
: 125597
351(a)
Vaxelis (Diphtheria and Tetanus Toxoids and Acellular Pertussis, Inactivated Poliovirus, Haemophilus b Conjugate and Hepatitis B Vaccine)
BLA Number
: 125563
351(a)
Vaxelis (Diphtheria and Tetanus Toxoids and Acellular Pertussis, Inactivated Poliovirus, Haemophilus b Conjugate and Hepatitis B Vaccine)
BLA Number
: 125563
351(a)
Vaxneuvance (Pneumococcal 15-valent Conjugate Vaccine)
BLA Number
: 125741
351(a)
Vectibix (panitumumab)
BLA Number
: 125147
351(a)
Vectibix (panitumumab)
BLA Number
: 125147
351(a)
Vectibix (panitumumab)
BLA Number
: 125147
351(a)
Vegzelma (bevacizumab-adcd)
BLA Number
: 761268
351(k) Biosimilar
Vegzelma (bevacizumab-adcd)
BLA Number
: 761268
351(k) Biosimilar
Veopoz (pozelimab-bbfg)
BLA Number
: 761339
351(a)
Verluma (nofetumomab)
BLA Number
: 103769
351(a)
Vimizim (elosulfase alfa)
BLA Number
: 125460
351(a)
VIMKUNYA (Chikungunya Vaccine, Recombinant)
BLA Number
: 125820
351(a)
Viokace (pancrelipase)
BLA Number
: 022542
351(a)
Viokace (pancrelipase)
BLA Number
: 022542
351(a)
Vistaseal (Fibrin Sealant (Human))
BLA Number
: 125640
351(a)
Vistaseal (Fibrin Sealant (Human))
BLA Number
: 125640
351(a)
Vistaseal (Fibrin Sealant (Human))
BLA Number
: 125640
351(a)
Vistaseal (Fibrin Sealant (Human))
BLA Number
: 125640
351(a)
Vitrase (hyaluronidase)
BLA Number
: 021640
351(a)
Vitrase (hyaluronidase)
BLA Number
: 021640
351(a)
Vivaglobin (Immune Globulin Subcutaneous (Human))
BLA Number
: 125115
351(a)
Vivotif (Typhoid Vaccine Live Oral Ty21a)
BLA Number
: 103123
351(a)
Vonvendi (von Willebrand factor (Recombinant))
BLA Number
: 125577
351(a)
Vonvendi (von Willebrand factor (Recombinant))
BLA Number
: 125577
351(a)
Voraxaze (glucarpidase)
BLA Number
: 125327
351(a)
Vowst (fecal microbiota spores, live-brpk)
BLA Number
: 125757
351(a)
Voyxact (sibeprenlimab-szsi)
BLA Number
: 761434
351(a)
VPRIV (velaglucerase alfa)
BLA Number
: 022575
351(a)
VPRIV (velaglucerase alfa)
BLA Number
: 022575
351(a)
Vyepti (eptinezumab-jjmr)
BLA Number
: 761119
351(a)
VYJUVEK (beremagene geperpavec-svdt)
BLA Number
: 125774
351(a)
Vyloy (zolbetuximab-clzb)
BLA Number
: 761365
351(a)
Vyloy (zolbetuximab-clzb)
BLA Number
: 761365
351(a)
Vyvgart (efgartigimod alfa-fcab)
BLA Number
: 761195
351(a)
Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc)
BLA Number
: 761304
351(a)
Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc)
BLA Number
: 761304
351(a)
waskyra (etuvetidigene autotemcel)
BLA Number
: 125846
351(a)
Wezlana (ustekinumab-auub)
BLA Number
: 761285
351(k) Interchangeable
Wezlana (ustekinumab-auub)
BLA Number
: 761285
351(k) Interchangeable
Wezlana (ustekinumab-auub)
BLA Number
: 761285
351(k) Interchangeable
Wezlana (ustekinumab-auub)
BLA Number
: 761331
351(k) Interchangeable
Wezlana (ustekinumab-auub)
BLA Number
: 761285
351(k) Biosimilar
Wezlana (ustekinumab-auub)
BLA Number
: 761285
351(k) Biosimilar
Wilate (von Willebrand Factor/Coagulation Factor VIII Complex (Human))
BLA Number
: 125251
351(a)
Wilate (von Willebrand Factor/Coagulation Factor VIII Complex (Human))
BLA Number
: 125251
351(a)
Winrevair (sotatercept-csrk)
BLA Number
: 761363
351(a)
Winrevair (sotatercept-csrk)
BLA Number
: 761363
351(a)
Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized (Rho(D) Immune Globulin Intravenous (Human))
BLA Number
: 103649
351(a)
Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized (Rho(D) Immune Globulin Intravenous (Human))
BLA Number
: 103649
351(a)
Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized (Rho(D) Immune Globulin Intravenous (Human))
BLA Number
: 103649
351(a)
Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized (Rho(D) Immune Globulin Intravenous (Human))
BLA Number
: 103649
351(a)
Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized (Rho(D) Immune Globulin Intravenous (Human))
BLA Number
: 103649
351(a)
Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized (Rho(D) Immune Globulin Intravenous (Human))
BLA Number
: 103649
351(a)
Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized (Rho(D) Immune Globulin Intravenous (Human))
BLA Number
: 103649
351(a)
Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized (Rho(D) Immune Globulin Intravenous (Human))
BLA Number
: 103649
351(a)
Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized (Rho(D) Immune Globulin Intravenous (Human))
BLA Number
: 103649
351(a)
Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized (Rho(D) Immune Globulin Intravenous (Human))
BLA Number
: 103649
351(a)
Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized (Rho(D) Immune Globulin Intravenous (Human))
BLA Number
: 103649
351(a)
Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized (Rho(D) Immune Globulin Intravenous (Human))
BLA Number
: 103649
351(a)
Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized (Rho(D) Immune Globulin Intravenous (Human))
BLA Number
: 103649
351(a)
Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized (Rho(D) Immune Globulin Intravenous (Human))
BLA Number
: 103649
351(a)
Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized (Rho(D) Immune Globulin Intravenous (Human))
BLA Number
: 103649
351(a)
Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized (Rho(D) Immune Globulin Intravenous (Human))
BLA Number
: 103649
351(a)
Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized (Rho(D) Immune Globulin Intravenous (Human))
BLA Number
: 103649
351(a)
Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized (Rho(D) Immune Globulin Intravenous (Human))
BLA Number
: 103649
351(a)
Wyost (denosumab-bbdz)
BLA Number
: 761362
351(k) Interchangeable
Xbryk (denosumab-dssb)
BLA Number
: 761392
351(k) Interchangeable
Xembify (immune globulin subcutaneous, human-klhw)
BLA Number
: 125683
351(a)
Xembify (immune globulin subcutaneous, human-klhw)
BLA Number
: 125683
351(a)
Xembify (immune globulin subcutaneous, human-klhw)
BLA Number
: 125683
351(a)
Xembify (immune globulin subcutaneous, human-klhw)
BLA Number
: 125683
351(a)
Xenpozyme (olipudase alfa-rpcp)
BLA Number
: 761261
351(a)
Xenpozyme (olipudase alfa-rpcp)
BLA Number
: 761261
351(a)
Xeomin (incobotulinumtoxinA)
BLA Number
: 125360
351(a)
Xeomin (incobotulinumtoxinA)
BLA Number
: 125360
351(a)
Xeomin (incobotulinumtoxinA)
BLA Number
: 125360
351(a)
Xgeva (denosumab)
BLA Number
: 125320
351(a)
Xiaflex (collagenase clostridium histolyticum)
BLA Number
: 125338
351(a)
Xigris (drotrecogin alfa)
BLA Number
: 125029
351(a)
Xigris (drotrecogin alfa)
BLA Number
: 125029
351(a)
Xolair (omalizumab)
BLA Number
: 103976
351(a)
Xolair (omalizumab)
BLA Number
: 103976
351(a)
Xolair (omalizumab)
BLA Number
: 103976
351(a)
Xolair (omalizumab)
BLA Number
: 103976
351(a)
Xolair (omalizumab)
BLA Number
: 103976
351(a)
Xolair (omalizumab)
BLA Number
: 103976
351(a)
Xolair (omalizumab)
BLA Number
: 103976
351(a)
Xtrenbo (denosumab-qbde)
BLA Number
: 761439
351(k) Interchangeable
Xultophy 100/3.6 (insulin degludec and liraglutide)
BLA Number
: 208583
351(a)
Xyntha, Xyntha Solofuse (Antihemophilic Factor (Recombinant), Plasma/Albumin Free)
BLA Number
: 125264
351(a)
Xyntha, Xyntha Solofuse (Antihemophilic Factor (Recombinant), Plasma/Albumin Free)
BLA Number
: 125264
351(a)
Xyntha, Xyntha Solofuse (Antihemophilic Factor (Recombinant), Plasma/Albumin Free)
BLA Number
: 125264
351(a)
Xyntha, Xyntha Solofuse (Antihemophilic Factor (Recombinant), Plasma/Albumin Free)
BLA Number
: 125264
351(a)
Xyntha, Xyntha Solofuse (Antihemophilic Factor (Recombinant), Plasma/Albumin Free)
BLA Number
: 125264
351(a)
Xyntha, Xyntha Solofuse (Antihemophilic Factor (Recombinant), Plasma/Albumin Free)
BLA Number
: 125264
351(a)
Xyntha, Xyntha Solofuse (Antihemophilic Factor (Recombinant), Plasma/Albumin Free)
BLA Number
: 125264
351(a)
Xyntha, Xyntha Solofuse (Antihemophilic Factor (Recombinant), Plasma/Albumin Free)
BLA Number
: 125264
351(a)
Xyntha, Xyntha Solofuse (Antihemophilic Factor (Recombinant), Plasma/Albumin Free)
BLA Number
: 125264
351(a)
Yartemlea (narsoplimab-wuug)
BLA Number
: 761152
351(a)
Yervoy (ipilimumab)
BLA Number
: 125377
351(a)
Yervoy (ipilimumab)
BLA Number
: 125377
351(a)
Yesafili (aflibercept-jbvf)
BLA Number
: 761274
351(k) Interchangeable
Yesafili (aflibercept-jbvf)
BLA Number
: 761274
351(k) Biosimilar
Yescarta (axicabtagene ciloleucel)
BLA Number
: 125643
351(a)
Yesintek (ustekinumab-kfce)
BLA Number
: 761406
351(k) Interchangeable
Yesintek (ustekinumab-kfce)
BLA Number
: 761406
351(k) Interchangeable
Yesintek (ustekinumab-kfce)
BLA Number
: 761406
351(k) Interchangeable
Yesintek (ustekinumab-kfce)
BLA Number
: 761406
351(k) Interchangeable
Yf-Vax (Yellow Fever Vaccine)
BLA Number
: 103915
351(a)
Yf-Vax (Yellow Fever Vaccine)
BLA Number
: 103915
351(a)
YIMMUGO (immune globulin intravenous, human-dira)
BLA Number
: 125810
351(a)
YIMMUGO (immune globulin intravenous, human-dira)
BLA Number
: 125810
351(a)
YIMMUGO (immune globulin intravenous, human-dira)
BLA Number
: 125810
351(a)
Yuflyma (adalimumab-aaty)
BLA Number
: 761219
351(k) Interchangeable
Yuflyma (adalimumab-aaty)
BLA Number
: 761219
351(k) Interchangeable
Yuflyma (adalimumab-aaty)
BLA Number
: 761219
351(k) Interchangeable
Yuflyma (adalimumab-aaty)
BLA Number
: 761219
351(k) Interchangeable
Yuflyma (adalimumab-aaty)
BLA Number
: 761219
351(k) Interchangeable
Yusimry (adalimumab-aqvh)
BLA Number
: 761216
351(k) Biosimilar
Yusimry (adalimumab-aqvh)
BLA Number
: 761216
351(k) Biosimilar
Zaltrap (Ziv-Aflibercept)
BLA Number
: 125418
351(a)
Zaltrap (Ziv-Aflibercept)
BLA Number
: 125418
351(a)
Zarxio (filgrastim-sndz)
BLA Number
: 125553
351(k) Biosimilar
Zarxio (filgrastim-sndz)
BLA Number
: 125553
351(k) Biosimilar
Zarxio (filgrastim-sndz)
BLA Number
: 125553
351(k) Biosimilar
Zarxio (filgrastim-sndz)
BLA Number
: 125553
351(k) Biosimilar
Zemaira (Alpha-1-Proteinase Inhibitor (Human))
BLA Number
: 125078
351(a)
Zemaira (Alpha-1-Proteinase Inhibitor (Human))
BLA Number
: 125078
351(a)
Zemaira (Alpha-1-Proteinase Inhibitor (Human))
BLA Number
: 125078
351(a)
Zenapax (daclizumab)
BLA Number
: 103749
351(a)
Zenpep (pancrelipase)
BLA Number
: 022210
351(a)
Zenpep (pancrelipase)
BLA Number
: 022210
351(a)
Zenpep (pancrelipase)
BLA Number
: 022210
351(a)
Zenpep (pancrelipase)
BLA Number
: 022210
351(a)
Zenpep (pancrelipase)
BLA Number
: 022210
351(a)
Zenpep (pancrelipase)
BLA Number
: 022210
351(a)
Zenpep (pancrelipase)
BLA Number
: 022210
351(a)
Zenpep (pancrelipase)
BLA Number
: 022210
351(a)
Zevalin (ibritumomab tiuxetan)
BLA Number
: 125019
351(a)
zevaskyn (Prademagene zamikeracel)
BLA Number
: 125807
351(a)
Ziextenzo (pegfilgrastim-bmez)
BLA Number
: 761045
351(k) Biosimilar
Ziihera (zanidatamab-hrii)
BLA Number
: 761416
351(a)
Zinbryta (daclizumab)
BLA Number
: 761029
351(a)
Zinbryta (daclizumab)
BLA Number
: 761029
351(a)
Zinplava (bezlotoxumab)
BLA Number
: 761046
351(a)
Zirabev (bevacizumab-bvzr)
BLA Number
: 761099
351(k) Biosimilar
Zirabev (bevacizumab-bvzr)
BLA Number
: 761099
351(k) Biosimilar
Zolgensma (onasemnogene abeparvovec-xioi)
BLA Number
: 125694
351(a)
Zomacton (somatropin)
BLA Number
: 019774
351(a)
Zomacton (somatropin)
BLA Number
: 019774
351(a)
Zomacton (somatropin)
BLA Number
: 019774
351(a)
Zorbtive/Serostim (somatropin)
BLA Number
: 020604
351(a)
Zostavax (Zoster Vaccine Live)
BLA Number
: 125123
351(a)
Zymfentra (infliximab-dyyb)
BLA Number
: 761358
351(a)
Zymfentra (infliximab-dyyb)
BLA Number
: 761358
351(a)
Zynlonta (loncastuximab tesirine-lpyl)
BLA Number
: 761196
351(a)
Zynteglo (betibeglogene autotemcel)
BLA Number
: 125717
351(a)
Zynyz (retifanlimab-dlwr)
BLA Number
: 761334
351(a)
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Database last updated: April 13, 2026
Glossary
Example: "Biosimilar"
351(a)
351(k) Biosimilar
351(k) Interchangeable
Applicant (sponsor)
Approval Date
Biological Product
Biosimilar
BLA
BLA Number
Center
Core Name
Date of First Licensure
Disc.
Disc.*
Dosage Form
Exclusivity Expiration Date
First Interchangeable
Exclusivity Expiration Date
Interchangeable
License Number
License Type
Licensure
Orphan Exclusivity Expiration Date
OTC (Over-the-Counter)
Patent List Provided
Product Number
Proper Name
Proprietary Name
Purple Book
Reference Product
Reference Product Exclusivity
Expiration Date
Route of Administration
Rx
Marketing Status
Strength
Submission Type
Supplement Number