Suppliers and packages for biologic ingredient: factor ix complex
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Suppliers and packages for biologic ingredient: factor ix complex
| Applicant | Tradename | Biologic Ingredient | Dosage | BLA | NDA/ANDA | Supplier | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| Grifols Biologicals Llc | PROFILNINE, PROFILNINE HP, PROFILNINE HT, PROFILNINE SD | factor ix complex | For Injection | 102476 | BLA | GRIFOLS USA, LLC | 68516-3207-1 | 1 KIT in 1 CARTON (68516-3207-1) * 5 mL in 1 VIAL (68516-3204-1) * 5 mL in 1 VIAL, SINGLE-DOSE (68516-1001-1) |
| Grifols Biologicals Llc | PROFILNINE, PROFILNINE HP, PROFILNINE HT, PROFILNINE SD | factor ix complex | For Injection | 102476 | BLA | GRIFOLS USA, LLC | 68516-3208-2 | 1 KIT in 1 CARTON (68516-3208-2) * 10 mL in 1 VIAL (68516-3205-2) * 10 mL in 1 VIAL, SINGLE-DOSE (68516-1002-2) |
| Grifols Biologicals Llc | PROFILNINE, PROFILNINE HP, PROFILNINE HT, PROFILNINE SD | factor ix complex | For Injection | 102476 | BLA | GRIFOLS USA, LLC | 68516-3209-2 | 1 KIT in 1 CARTON (68516-3209-2) * 10 mL in 1 VIAL (68516-3206-2) * 10 mL in 1 VIAL, SINGLE-DOSE (68516-1002-2) |
| Grifols Biologicals Llc | PROFILNINE, PROFILNINE HP, PROFILNINE HT, PROFILNINE SD | factor ix complex | For Injection | 102476 | BLA | GRIFOLS USA, LLC | 68516-3210-1 | 1 KIT in 1 CARTON (68516-3210-1) * 5 mL in 1 VIAL (68516-3204-1) * 5 mL in 1 VIAL, GLASS (76297-002-02) |
| Grifols Biologicals Llc | PROFILNINE, PROFILNINE HP, PROFILNINE HT, PROFILNINE SD | factor ix complex | For Injection | 102476 | BLA | GRIFOLS USA, LLC | 68516-3211-2 | 1 KIT in 1 CARTON (68516-3211-2) * 10 mL in 1 VIAL (68516-3205-2) * 10 mL in 1 VIAL, GLASS (76297-002-12) |
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