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) |
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