Suppliers and packages for biologic ingredient: antihemophilic factor (recombinant), pegylated-aucl
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Suppliers and packages for biologic ingredient: antihemophilic factor (recombinant), pegylated-aucl
| Applicant | Tradename | Biologic Ingredient | Dosage | BLA | NDA/ANDA | Supplier | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| Bayer Healthcare Llc | JIVI | antihemophilic factor (recombinant), pegylated-aucl | For Injection | 125661 | BLA | Bayer HealthCare LLC | 0026-3942-25 | 1 KIT in 1 BOX (0026-3942-25) * 2.5 mL in 1 VIAL (0026-4942-99) * 2.5 mL in 1 SYRINGE (0026-0426-02) * 2.5 mL in 1 VIAL, SINGLE-USE (0026-4942-01) |
| Bayer Healthcare Llc | JIVI | antihemophilic factor (recombinant), pegylated-aucl | For Injection | 125661 | BLA | Bayer HealthCare LLC | 0026-3942-99 | 1 KIT in 1 BOX (0026-3942-99) * 2.5 mL in 1 VIAL (0026-4942-99) * 2.5 mL in 1 SYRINGE (0026-0426-02) * 2.5 mL in 1 VIAL, SINGLE-USE (0026-4942-01) |
| Bayer Healthcare Llc | JIVI | antihemophilic factor (recombinant), pegylated-aucl | For Injection | 125661 | BLA | Bayer HealthCare LLC | 0026-3944-25 | 1 KIT in 1 BOX (0026-3944-25) * 2.5 mL in 1 VIAL (0026-4944-99) * 2.5 mL in 1 SYRINGE (0026-0426-02) * 2.5 mL in 1 VIAL, SINGLE-USE (0026-4944-01) |
| Bayer Healthcare Llc | JIVI | antihemophilic factor (recombinant), pegylated-aucl | For Injection | 125661 | BLA | Bayer HealthCare LLC | 0026-3944-99 | 1 KIT in 1 BOX (0026-3944-99) * 2.5 mL in 1 VIAL (0026-4944-99) * 2.5 mL in 1 SYRINGE (0026-0426-02) * 2.5 mL in 1 VIAL, SINGLE-USE (0026-4944-01) |
| Bayer Healthcare Llc | JIVI | antihemophilic factor (recombinant), pegylated-aucl | For Injection | 125661 | BLA | Bayer HealthCare LLC | 0026-3946-25 | 1 KIT in 1 BOX (0026-3946-25) * 2.5 mL in 1 VIAL (0026-4946-99) * 2.5 mL in 1 SYRINGE (0026-0426-02) * 2.5 mL in 1 VIAL, SINGLE-USE (0026-4946-01) |
| Bayer Healthcare Llc | JIVI | antihemophilic factor (recombinant), pegylated-aucl | For Injection | 125661 | BLA | Bayer HealthCare LLC | 0026-3946-99 | 1 KIT in 1 BOX (0026-3946-99) * 2.5 mL in 1 VIAL (0026-4946-99) * 2.5 mL in 1 SYRINGE (0026-0426-02) * 2.5 mL in 1 VIAL, SINGLE-USE (0026-4946-01) |
| Bayer Healthcare Llc | JIVI | antihemophilic factor (recombinant), pegylated-aucl | For Injection | 125661 | BLA | Bayer HealthCare LLC | 0026-3948-25 | 1 KIT in 1 BOX (0026-3948-25) * 2.5 mL in 1 VIAL (0026-4948-99) * 2.5 mL in 1 SYRINGE (0026-0426-02) * 2.5 mL in 1 VIAL, SINGLE-USE (0026-4948-01) |
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