Suppliers and packages for biologic ingredient: coagulation factor ix (recombinant), fc fusion protein
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Suppliers and packages for biologic ingredient: coagulation factor ix (recombinant), fc fusion protein
| Applicant | Tradename | Biologic Ingredient | Dosage | BLA | NDA/ANDA | Supplier | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| Bioverativ Therapeutics, Inc. | ALPROLIX | coagulation factor ix (recombinant), fc fusion protein | For Injection | 125444 | BLA | Bioverativ Therapeutics Inc. | 71104-911-01 | 1 KIT in 1 KIT (71104-911-01) * 5 mL in 1 VIAL (71104-953-09) * 5 mL in 1 VIAL (71104-045-01) |
| Bioverativ Therapeutics, Inc. | ALPROLIX | coagulation factor ix (recombinant), fc fusion protein | For Injection | 125444 | BLA | Bioverativ Therapeutics Inc. | 71104-922-01 | 1 KIT in 1 KIT (71104-922-01) * 5 mL in 1 VIAL (71104-954-09) * 5 mL in 1 VIAL (71104-045-01) |
| Bioverativ Therapeutics, Inc. | ALPROLIX | coagulation factor ix (recombinant), fc fusion protein | For Injection | 125444 | BLA | Bioverativ Therapeutics Inc. | 71104-933-01 | 1 KIT in 1 KIT (71104-933-01) * 5 mL in 1 VIAL (71104-955-09) * 5 mL in 1 VIAL (71104-045-01) |
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