Suppliers and packages for biologic ingredient: tetanus and diphtheria toxoids adsorbed
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Suppliers and packages for biologic ingredient: tetanus and diphtheria toxoids adsorbed
| Applicant | Tradename | Biologic Ingredient | Dosage | BLA | NDA/ANDA | Supplier | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| Massbiologics | TDVAX | tetanus and diphtheria toxoids adsorbed | Injection | 101322 | BLA | Grifols USA, LLC | 13533-131-01 | 10 VIAL, SINGLE-DOSE in 1 CARTON (13533-131-01) / .5 mL in 1 VIAL, SINGLE-DOSE (13533-131-00) |
| Massbiologics | TDVAX | tetanus and diphtheria toxoids adsorbed | Injection | 101322 | BLA | MassBiologics | 14362-0111-4 | 10 VIAL, SINGLE-DOSE in 1 CARTON (14362-0111-4) / .5 mL in 1 VIAL, SINGLE-DOSE (14362-0111-3) |
| Sanofi Pasteur Limited | TENIVAC | tetanus and diphtheria toxoids adsorbed | Injection | 103171 | BLA | Sanofi Pasteur Inc. | 49281-215-10 | 10 VIAL, SINGLE-DOSE in 1 PACKAGE (49281-215-10) / .5 mL in 1 VIAL, SINGLE-DOSE (49281-215-58) |
| Sanofi Pasteur Limited | TENIVAC | tetanus and diphtheria toxoids adsorbed | Injection | 103171 | BLA | Sanofi Pasteur Inc. | 49281-215-15 | 10 SYRINGE in 1 PACKAGE (49281-215-15) / .5 mL in 1 SYRINGE (49281-215-88) |
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