Suppliers and packages for biologic ingredient: antihemophilic factor (recombinant)
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Suppliers and packages for biologic ingredient: antihemophilic factor (recombinant)
| Applicant | Tradename | Biologic Ingredient | Dosage | BLA | NDA/ANDA | Supplier | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| Baxalta Us Inc. | BIOCLATE (ARMOUR), RECOMBINATE | antihemophilic factor (recombinant) | For Injection | 103375 | BLA | Takeda Pharmaceuticals America, Inc. | 0944-2841-10 | 1 KIT in 1 CARTON (0944-2841-10) * 10 mL in 1 VIAL, GLASS (0944-2831-01) * 5 mL in 1 VIAL, GLASS (64764-515-50) |
| Baxalta Us Inc. | BIOCLATE (ARMOUR), RECOMBINATE | antihemophilic factor (recombinant) | For Injection | 103375 | BLA | Takeda Pharmaceuticals America, Inc. | 0944-2842-10 | 1 KIT in 1 CARTON (0944-2842-10) * 10 mL in 1 VIAL, GLASS (0944-2832-01) * 5 mL in 1 VIAL, GLASS (64764-515-50) |
| Baxalta Us Inc. | BIOCLATE (ARMOUR), RECOMBINATE | antihemophilic factor (recombinant) | For Injection | 103375 | BLA | Takeda Pharmaceuticals America, Inc. | 0944-2843-10 | 1 KIT in 1 CARTON (0944-2843-10) * 10 mL in 1 VIAL, GLASS (0944-2833-01) * 5 mL in 1 VIAL, GLASS (64764-515-50) |
| Baxalta Us Inc. | BIOCLATE (ARMOUR), RECOMBINATE | antihemophilic factor (recombinant) | For Injection | 103375 | BLA | Takeda Pharmaceuticals America, Inc. | 0944-2844-10 | 1 KIT in 1 CARTON (0944-2844-10) * 10 mL in 1 VIAL, GLASS (0944-2834-01) * 5 mL in 1 VIAL, GLASS (64764-515-50) |
| Baxalta Us Inc. | BIOCLATE (ARMOUR), RECOMBINATE | antihemophilic factor (recombinant) | For Injection | 103375 | BLA | Takeda Pharmaceuticals America, Inc. | 0944-2845-10 | 1 KIT in 1 CARTON (0944-2845-10) * 10 mL in 1 VIAL, GLASS (0944-2835-01) * 5 mL in 1 VIAL, GLASS (64764-515-50) |
| Novo Nordisk Inc. | NOVOEIGHT | antihemophilic factor (recombinant) | For Injection | 125466 | BLA | Novo Nordisk | 0169-7810-01 | 1 KIT in 1 KIT (0169-7810-01) * 4 mL in 1 VIAL, GLASS (0169-7811-11) * 4 mL in 1 SYRINGE, GLASS (0169-7008-98) |
| >Applicant | >Tradename | >Biologic Ingredient | >Dosage | >BLA | >NDA/ANDA | >Supplier | >Package Code | >Package |
