Suppliers and packages for biologic ingredient: coagulation factor ix (recombinant)
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Suppliers and packages for biologic ingredient: coagulation factor ix (recombinant)
| Applicant | Tradename | Biologic Ingredient | Dosage | BLA | NDA/ANDA | Supplier | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| Wyeth Pharmaceuticals Llc | BENEFIX, BENEFIX RTS | coagulation factor ix (recombinant) | For Injection | 103677 | BLA | Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC | 58394-633-03 | 1 KIT in 1 CARTON (58394-633-03) * 5 mL in 1 SYRINGE (58394-041-11) * 1 mL in 1 PACKET (0069-1111-01) * 5 mL in 1 VIAL, SINGLE-USE (58394-133-03) |
| Wyeth Pharmaceuticals Llc | BENEFIX, BENEFIX RTS | coagulation factor ix (recombinant) | For Injection | 103677 | BLA | Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC | 58394-634-03 | 1 KIT in 1 CARTON (58394-634-03) * 5 mL in 1 SYRINGE (58394-041-11) * 1 mL in 1 PACKET (0069-1111-01) * 5 mL in 1 VIAL, SINGLE-USE (58394-134-03) |
| Wyeth Pharmaceuticals Llc | BENEFIX, BENEFIX RTS | coagulation factor ix (recombinant) | For Injection | 103677 | BLA | Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC | 58394-635-03 | 1 KIT in 1 CARTON (58394-635-03) * 5 mL in 1 SYRINGE (58394-041-11) * 1 mL in 1 PACKET (0069-1111-01) * 5 mL in 1 VIAL, SINGLE-USE (58394-135-03) |
| Wyeth Pharmaceuticals Llc | BENEFIX, BENEFIX RTS | coagulation factor ix (recombinant) | For Injection | 103677 | BLA | Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC | 58394-636-03 | 1 KIT in 1 CARTON (58394-636-03) * 5 mL in 1 SYRINGE (58394-041-11) * 1 mL in 1 PACKET (0069-1111-01) * 5 mL in 1 VIAL, SINGLE-USE (58394-136-03) |
| Wyeth Pharmaceuticals Llc | BENEFIX, BENEFIX RTS | coagulation factor ix (recombinant) | For Injection | 103677 | BLA | Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC | 58394-637-03 | 1 KIT in 1 CARTON (58394-637-03) * 5 mL in 1 SYRINGE (58394-041-11) * 1 mL in 1 PACKET (0069-1111-01) * 5 mL in 1 VIAL, SINGLE-USE (58394-137-03) |
| Medexus Pharma, Inc. | IXINITY | coagulation factor ix (recombinant) | For Injection | 125426 | BLA | Medexus Pharma, Inc. | 59137-282-05 | 1 KIT in 1 CARTON (59137-282-05) * 5 mL in 1 VIAL (59137-270-01) * 5 mL in 1 SYRINGE (59137-280-01) |
| Medexus Pharma, Inc. | IXINITY | coagulation factor ix (recombinant) | For Injection | 125426 | BLA | Medexus Pharma, Inc. | 59137-283-05 | 1 KIT in 1 CARTON (59137-283-05) * 5 mL in 1 VIAL (59137-271-01) * 5 mL in 1 SYRINGE (59137-280-01) |
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