Suppliers and packages for biologic ingredient: adalimumab-fkjp
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Suppliers and packages for biologic ingredient: adalimumab-fkjp
| Applicant | Tradename | Biologic Ingredient | Dosage | BLA | NDA/ANDA | Supplier | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| Mylan Pharmaceuticals Inc. | HULIO | adalimumab-fkjp | Injection | 761154 | BLA | Mylan Specialty L.P. | 49502-380-02 | 2 TRAY in 1 KIT (49502-380-02) / 1 KIT in 1 TRAY * 2 TRAY in 1 KIT (49502-540-06) / 1 SYRINGE in 1 TRAY / .8 mL in 1 SYRINGE * 2 PACKET in 1 KIT (49502-542-06) / 1 mL in 1 PACKET |
| Mylan Pharmaceuticals Inc. | HULIO | adalimumab-fkjp | Injection | 761154 | BLA | Mylan Specialty L.P. | 49502-381-02 | 2 TRAY in 1 KIT (49502-381-02) / 1 KIT in 1 TRAY * 2 TRAY in 1 KIT (49502-567-06) / 1 SYRINGE in 1 TRAY / .4 mL in 1 SYRINGE * 2 PACKET in 1 KIT (49502-569-02) / 1 mL in 1 PACKET |
| Mylan Pharmaceuticals Inc. | HULIO | adalimumab-fkjp | Injection | 761154 | BLA | Mylan Specialty L.P. | 49502-382-02 | 2 TRAY in 1 KIT (49502-382-02) / 1 KIT in 1 TRAY * 2 TRAY in 1 KIT (49502-554-06) / 1 SYRINGE in 1 TRAY / .8 mL in 1 SYRINGE * 2 PACKET in 1 KIT (49502-556-06) / 1 mL in 1 PACKET |
| Mylan Pharmaceuticals Inc. | HULIO | adalimumab-fkjp | Injection | 761154 | BLA | Mylan Specialty L.P. | 49502-416-02 | 2 TRAY in 1 KIT (49502-416-02) / 1 KIT in 1 TRAY * 2 TRAY in 1 KIT (49502-480-06) / 1 SYRINGE in 1 TRAY / .8 mL in 1 SYRINGE * 2 PACKET in 1 KIT (49502-481-06) / 1 mL in 1 PACKET |
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