Suppliers and packages for biologic ingredient: coagulation factor ix (recombinant), glycopegylated
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Suppliers and packages for biologic ingredient: coagulation factor ix (recombinant), glycopegylated
| Applicant | Tradename | Biologic Ingredient | Dosage | BLA | NDA/ANDA | Supplier | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| Novo Nordisk Inc. | REBINYN | coagulation factor ix (recombinant), glycopegylated | For Injection | 125611 | BLA | Novo Nordisk | 0169-7901-01 | 1 KIT in 1 KIT (0169-7901-01) * 4 mL in 1 VIAL, GLASS (0169-7911-90) * 4 mL in 1 SYRINGE, GLASS (0169-7009-98) * 4 mL in 1 VIAL, GLASS (0169-7911-11) |
| Novo Nordisk Inc. | REBINYN | coagulation factor ix (recombinant), glycopegylated | For Injection | 125611 | BLA | Novo Nordisk | 0169-7901-97 | 1 KIT in 1 KIT (0169-7901-97) * 4 mL in 1 VIAL, GLASS (0169-7911-90) * 4 mL in 1 SYRINGE, GLASS (0169-7009-98) * 4 mL in 1 VIAL, GLASS (0169-7911-11) |
| Novo Nordisk Inc. | REBINYN | coagulation factor ix (recombinant), glycopegylated | For Injection | 125611 | BLA | Novo Nordisk | 0169-7902-01 | 1 KIT in 1 KIT (0169-7902-01) * 4 mL in 1 VIAL, GLASS (0169-7922-90) * 4 mL in 1 SYRINGE, GLASS (0169-7009-98) * 4 mL in 1 VIAL, GLASS (0169-7922-11) |
| Novo Nordisk Inc. | REBINYN | coagulation factor ix (recombinant), glycopegylated | For Injection | 125611 | BLA | Novo Nordisk | 0169-7902-97 | 1 KIT in 1 KIT (0169-7902-97) * 4 mL in 1 VIAL, GLASS (0169-7922-90) * 4 mL in 1 SYRINGE, GLASS (0169-7009-98) * 4 mL in 1 VIAL, GLASS (0169-7922-11) |
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