Suppliers and packages for biologic ingredient: onasemnogene abeparvovec
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Suppliers and packages for biologic ingredient: onasemnogene abeparvovec
| Applicant | Tradename | Biologic Ingredient | Dosage | BLA | NDA/ANDA | Supplier | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| Novartis Gene Therapies, Inc. | ZOLGENSMA | onasemnogene abeparvovec | Injection | 125694 | BLA | Novartis Gene Therapies, Inc. | 71894-120-02 | 1 KIT in 1 CARTON (71894-120-02) * 8.3 mL in 1 VIAL (71894-115-01) * 1 mL in 1 POUCH |
| Novartis Gene Therapies, Inc. | ZOLGENSMA | onasemnogene abeparvovec | Injection | 125694 | BLA | Novartis Gene Therapies, Inc. | 71894-121-03 | 1 KIT in 1 CARTON (71894-121-03) * 5.5 mL in 1 VIAL (71894-110-01) * 8.3 mL in 1 VIAL (71894-115-01) * 1 mL in 1 POUCH |
| Novartis Gene Therapies, Inc. | ZOLGENSMA | onasemnogene abeparvovec | Injection | 125694 | BLA | Novartis Gene Therapies, Inc. | 71894-122-03 | 1 KIT in 1 CARTON (71894-122-03) * 8.3 mL in 1 VIAL (71894-115-01) * 1 mL in 1 POUCH * 5.5 mL in 1 VIAL (71894-110-01) |
| Novartis Gene Therapies, Inc. | ZOLGENSMA | onasemnogene abeparvovec | Injection | 125694 | BLA | Novartis Gene Therapies, Inc. | 71894-123-03 | 1 KIT in 1 CARTON (71894-123-03) * 8.3 mL in 1 VIAL (71894-115-01) * 1 mL in 1 POUCH |
| Novartis Gene Therapies, Inc. | ZOLGENSMA | onasemnogene abeparvovec | Injection | 125694 | BLA | Novartis Gene Therapies, Inc. | 71894-124-04 | 1 KIT in 1 CARTON (71894-124-04) * 1 mL in 1 POUCH * 5.5 mL in 1 VIAL (71894-110-01) * 8.3 mL in 1 VIAL (71894-115-01) |
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