Suppliers and packages for biologic ingredient: antihemophilic factor (human)
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Suppliers and packages for biologic ingredient: antihemophilic factor (human)
Applicant | Tradename | Biologic Ingredient | Dosage | BLA | NDA/ANDA | Supplier | Package Code | Package |
---|---|---|---|---|---|---|---|---|
Grifols Therapeutics Llc | KOATE, KOATE-DVI | antihemophilic factor (human) | For Injection | 101130 | BLA | KEDRION BIOPHARMA, INC. | 76125-250-20 | 1 KIT in 1 CARTON (76125-250-20) * 5 mL in 1 VIAL, GLASS (76125-252-21) * 5 mL in 1 VIAL, GLASS (13533-000-04) |
Grifols Therapeutics Llc | KOATE, KOATE-DVI | antihemophilic factor (human) | For Injection | 101130 | BLA | KEDRION BIOPHARMA, INC. | 76125-253-25 | 1 KIT in 1 CARTON (76125-253-25) * 5 mL in 1 VIAL, GLASS (76125-252-21) * 5 mL in 1 VIAL, GLASS (13533-200-05) |
Grifols Therapeutics Llc | KOATE, KOATE-DVI | antihemophilic factor (human) | For Injection | 101130 | BLA | KEDRION BIOPHARMA, INC. | 76125-256-20 | 1 KIT in 1 CARTON (76125-256-20) * 5 mL in 1 VIAL, GLASS (76125-252-21) * 5 mL in 1 VIAL, GLASS (13533-000-04) |
Grifols Therapeutics Llc | KOATE, KOATE-DVI | antihemophilic factor (human) | For Injection | 101130 | BLA | KEDRION BIOPHARMA, INC. | 76125-257-25 | 1 KIT in 1 CARTON (76125-257-25) * 5 mL in 1 VIAL, GLASS (13533-200-05) * 5 mL in 1 VIAL, GLASS (76125-252-21) |
Grifols Therapeutics Llc | KOATE, KOATE-DVI | antihemophilic factor (human) | For Injection | 101130 | BLA | KEDRION BIOPHARMA, INC. | 76125-258-02 | 1 KIT in 1 CARTON (76125-258-02) * 5 mL in 1 VIAL, GLASS (76125-252-21) * 5 mL in 1 VIAL, GLASS (76297-002-02) |
Grifols Therapeutics Llc | KOATE, KOATE-DVI | antihemophilic factor (human) | For Injection | 101130 | BLA | KEDRION BIOPHARMA, INC. | 76125-259-02 | 1 KIT in 1 CARTON (76125-259-02) * 5 mL in 1 VIAL, GLASS (76125-252-21) * 5 mL in 1 VIAL, GLASS (76297-002-02) |
Grifols Therapeutics Llc | KOATE, KOATE-DVI | antihemophilic factor (human) | For Injection | 101130 | BLA | KEDRION BIOPHARMA, INC. | 76125-661-02 | 1 KIT in 1 CARTON (76125-661-02) * 5 mL in 1 VIAL, GLASS (76125-669-31) * 5 mL in 1 VIAL, GLASS (76297-002-02) |
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