Suppliers and packages for biologic ingredient: antihemophilic factor (recombinant), full length
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Suppliers and packages for biologic ingredient: antihemophilic factor (recombinant), full length
| Applicant | Tradename | Biologic Ingredient | Dosage | BLA | NDA/ANDA | Supplier | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| Bayer Healthcare Llc | KOVALTRY | antihemophilic factor (recombinant), full length | For Injection | 125574 | BLA | Bayer HealthCare LLC | 0026-3821-25 | 1 KIT in 1 BOX (0026-3821-25) * 2.5 mL in 1 VIAL, SINGLE-USE (0026-4821-99) * 2.5 mL in 1 SYRINGE (0026-0426-02) * 2.5 mL in 1 VIAL, SINGLE-USE (0026-4821-01) |
| Bayer Healthcare Llc | KOVALTRY | antihemophilic factor (recombinant), full length | For Injection | 125574 | BLA | Bayer HealthCare LLC | 0026-3821-99 | 1 KIT in 1 BOX (0026-3821-99) * 2.5 mL in 1 VIAL, SINGLE-USE (0026-4821-99) * 2.5 mL in 1 SYRINGE (0026-0426-02) * 2.5 mL in 1 VIAL, SINGLE-USE (0026-4821-01) |
| Bayer Healthcare Llc | KOVALTRY | antihemophilic factor (recombinant), full length | For Injection | 125574 | BLA | Bayer HealthCare LLC | 0026-3822-25 | 1 KIT in 1 BOX (0026-3822-25) * 2.5 mL in 1 VIAL, SINGLE-USE (0026-4822-99) * 2.5 mL in 1 SYRINGE (0026-0426-02) * 2.5 mL in 1 VIAL, SINGLE-USE (0026-4822-01) |
| Bayer Healthcare Llc | KOVALTRY | antihemophilic factor (recombinant), full length | For Injection | 125574 | BLA | Bayer HealthCare LLC | 0026-3822-99 | 1 KIT in 1 BOX (0026-3822-99) * 2.5 mL in 1 VIAL, SINGLE-USE (0026-4822-99) * 2.5 mL in 1 SYRINGE (0026-0426-02) * 2.5 mL in 1 VIAL, SINGLE-USE (0026-4822-01) |
| Bayer Healthcare Llc | KOVALTRY | antihemophilic factor (recombinant), full length | For Injection | 125574 | BLA | Bayer HealthCare LLC | 0026-3824-25 | 1 KIT in 1 BOX (0026-3824-25) * 2.5 mL in 1 VIAL, SINGLE-USE (0026-4824-99) * 2.5 mL in 1 SYRINGE (0026-0426-02) * 2.5 mL in 1 VIAL, SINGLE-USE (0026-4824-01) |
| Bayer Healthcare Llc | KOVALTRY | antihemophilic factor (recombinant), full length | For Injection | 125574 | BLA | Bayer HealthCare LLC | 0026-3824-99 | 1 KIT in 1 BOX (0026-3824-99) * 2.5 mL in 1 VIAL, SINGLE-USE (0026-4824-99) * 2.5 mL in 1 SYRINGE (0026-0426-02) * 2.5 mL in 1 VIAL, SINGLE-USE (0026-4824-01) |
| Bayer Healthcare Llc | KOVALTRY | antihemophilic factor (recombinant), full length | For Injection | 125574 | BLA | Bayer HealthCare LLC | 0026-3826-50 | 1 KIT in 1 BOX (0026-3826-50) * 5 mL in 1 SYRINGE (0026-0426-15) * 5 mL in 1 VIAL, SINGLE-USE (0026-4826-99) * 5 mL in 1 SYRINGE (0026-0426-05) * 5 mL in 1 VIAL, SINGLE-USE (0026-4826-01) |
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