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 |
|---|---|---|---|---|---|---|---|---|
| Bayer Healthcare Llc | HELIXATE FS, KOGENATE, KOGENATE FS | antihemophilic factor (recombinant) | For Injection | 103332 | BLA | Bayer HealthCare LLC | 0026-3782-25 | 1 KIT in 1 BOX (0026-3782-25) * 2.5 mL in 1 VIAL, SINGLE-USE (0026-4782-01) * 2.5 mL in 1 SYRINGE (0026-0426-02) |
| Bayer Healthcare Llc | HELIXATE FS, KOGENATE, KOGENATE FS | antihemophilic factor (recombinant) | For Injection | 103332 | BLA | Bayer HealthCare LLC | 0026-3783-35 | 1 KIT in 1 BOX (0026-3783-35) * 2.5 mL in 1 VIAL, SINGLE-USE (0026-4783-01) * 2.5 mL in 1 SYRINGE (0026-0426-02) |
| Bayer Healthcare Llc | HELIXATE FS, KOGENATE, KOGENATE FS | antihemophilic factor (recombinant) | For Injection | 103332 | BLA | Bayer HealthCare LLC | 0026-3785-55 | 1 KIT in 1 BOX (0026-3785-55) * 2.5 mL in 1 VIAL, SINGLE-USE (0026-4785-01) * 2.5 mL in 1 SYRINGE (0026-0426-02) |
| Bayer Healthcare Llc | HELIXATE FS, KOGENATE, KOGENATE FS | antihemophilic factor (recombinant) | For Injection | 103332 | BLA | Bayer HealthCare LLC | 0026-3786-65 | 1 KIT in 1 BOX (0026-3786-65) * 5 mL in 1 VIAL, SINGLE-USE (0026-4786-01) * 5 mL in 1 SYRINGE (0026-0426-05) |
| Bayer Healthcare Llc | HELIXATE FS, KOGENATE, KOGENATE FS | antihemophilic factor (recombinant) | For Injection | 103332 | BLA | Bayer HealthCare LLC | 0026-3787-75 | 1 KIT in 1 BOX (0026-3787-75) * 5 mL in 1 VIAL, SINGLE-USE (0026-4787-01) * 5 mL in 1 SYRINGE (0026-0426-05) |
| 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) |
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