Suppliers and packages for biologic ingredient: antihemophilic factor (recombinant), pegylated
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Suppliers and packages for biologic ingredient: antihemophilic factor (recombinant), pegylated
| Applicant | Tradename | Biologic Ingredient | Dosage | BLA | NDA/ANDA | Supplier | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| Baxalta Us Inc. | ADYNOVATE | antihemophilic factor (recombinant), pegylated | For Injection | 125566 | BLA | Takeda Pharmaceuticals Amercia, Inc. | 0944-4622-01 | 1 KIT in 1 CARTON (0944-4622-01) / 1 CONTAINER in 1 KIT (0944-4622-02) / 1 KIT in 1 CONTAINER (0944-4622-03) * 5 mL in 1 VIAL, GLASS (0944-4137-01) * 2 mL in 1 VIAL, GLASS (64764-514-02) |
| Baxalta Us Inc. | ADYNOVATE | antihemophilic factor (recombinant), pegylated | For Injection | 125566 | BLA | Takeda Pharmaceuticals Amercia, Inc. | 0944-4623-01 | 1 KIT in 1 CARTON (0944-4623-01) / 1 CONTAINER in 1 KIT (0944-4623-02) / 1 KIT in 1 CONTAINER (0944-4623-03) * 5 mL in 1 VIAL, GLASS (0944-4138-01) * 2 mL in 1 VIAL, GLASS (64764-514-02) |
| Baxalta Us Inc. | ADYNOVATE | antihemophilic factor (recombinant), pegylated | For Injection | 125566 | BLA | Takeda Pharmaceuticals Amercia, Inc. | 0944-4624-01 | 1 KIT in 1 CARTON (0944-4624-01) / 1 CONTAINER in 1 KIT (0944-4624-02) / 1 KIT in 1 CONTAINER (0944-4624-03) * 5 mL in 1 VIAL, GLASS (0944-4140-01) * 2 mL in 1 VIAL, GLASS (64764-514-02) |
| Baxalta Us Inc. | ADYNOVATE | antihemophilic factor (recombinant), pegylated | For Injection | 125566 | BLA | Takeda Pharmaceuticals Amercia, Inc. | 0944-4625-01 | 1 KIT in 1 CARTON (0944-4625-01) / 1 CONTAINER in 1 KIT (0944-4625-02) / 1 KIT in 1 CONTAINER (0944-4625-03) * 5 mL in 1 VIAL, GLASS (0944-4257-01) * 5 mL in 1 VIAL, GLASS (64764-515-50) |
| Baxalta Us Inc. | ADYNOVATE | antihemophilic factor (recombinant), pegylated | For Injection | 125566 | BLA | Takeda Pharmaceuticals Amercia, Inc. | 0944-4626-01 | 1 KIT in 1 CARTON (0944-4626-01) / 1 CONTAINER in 1 KIT (0944-4626-02) / 1 KIT in 1 CONTAINER (0944-4626-03) * 5 mL in 1 VIAL, GLASS (0944-4139-01) * 2 mL in 1 VIAL, GLASS (64764-514-02) |
| Baxalta Us Inc. | ADYNOVATE | antihemophilic factor (recombinant), pegylated | For Injection | 125566 | BLA | Takeda Pharmaceuticals Amercia, Inc. | 0944-4627-01 | 1 KIT in 1 CARTON (0944-4627-01) / 1 CONTAINER in 1 KIT (0944-4627-02) / 1 KIT in 1 CONTAINER (0944-4627-03) * 2 mL in 1 VIAL, GLASS (64764-514-02) * 5 mL in 1 VIAL, GLASS (0944-4141-01) |
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