Suppliers and packages for biologic ingredient: coagulation factor ix (human)
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Suppliers and packages for biologic ingredient: coagulation factor ix (human)
| Applicant | Tradename | Biologic Ingredient | Dosage | BLA | NDA/ANDA | Supplier | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| Grifols Biologicals Llc | ALPHANINE, ALPHANINE HP, ALPHANINE SD | coagulation factor ix (human) | Injection | 103249 | BLA | GRIFOLS USA, LLC | 68516-3607-2 | 1 KIT in 1 CARTON (68516-3607-2) * 10 mL in 1 VIAL (68516-3604-2) * 10 mL in 1 VIAL, SINGLE-DOSE (68516-1002-2) |
| Grifols Biologicals Llc | ALPHANINE, ALPHANINE HP, ALPHANINE SD | coagulation factor ix (human) | Injection | 103249 | BLA | GRIFOLS USA, LLC | 68516-3608-2 | 1 KIT in 1 CARTON (68516-3608-2) * 10 mL in 1 VIAL (68516-3605-2) * 10 mL in 1 VIAL, SINGLE-DOSE (68516-1002-2) |
| Grifols Biologicals Llc | ALPHANINE, ALPHANINE HP, ALPHANINE SD | coagulation factor ix (human) | Injection | 103249 | BLA | GRIFOLS USA, LLC | 68516-3609-2 | 1 KIT in 1 CARTON (68516-3609-2) * 10 mL in 1 VIAL (68516-3606-2) * 10 mL in 1 VIAL, SINGLE-DOSE (68516-1002-2) |
| Grifols Biologicals Llc | ALPHANINE, ALPHANINE HP, ALPHANINE SD | coagulation factor ix (human) | Injection | 103249 | BLA | GRIFOLS USA, LLC | 68516-3610-2 | 1 KIT in 1 CARTON (68516-3610-2) * 10 mL in 1 VIAL (68516-3604-2) * 10 mL in 1 VIAL, GLASS (76297-002-12) |
| Grifols Biologicals Llc | ALPHANINE, ALPHANINE HP, ALPHANINE SD | coagulation factor ix (human) | Injection | 103249 | BLA | GRIFOLS USA, LLC | 68516-3611-2 | 1 KIT in 1 CARTON (68516-3611-2) * 10 mL in 1 VIAL, GLASS (76297-002-12) * 10 mL in 1 VIAL (68516-3605-2) |
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