Suppliers and packages for biologic ingredient: alpha-1-proteinase inhibitor (human)
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Suppliers and packages for biologic ingredient: alpha-1-proteinase inhibitor (human)
| Applicant | Tradename | Biologic Ingredient | Dosage | BLA | NDA/ANDA | Supplier | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| Grifols Therapeutics Llc | PROLASTIN, PROLASTIN-C | alpha-1-proteinase inhibitor (human) | For Injection | 103174 | BLA | GRIFOLS USA, LLC | 13533-700-02 | 1 KIT in 1 CARTON (13533-700-02) * 20 mL in 1 VIAL, SINGLE-DOSE (13533-702-11) * 20 mL in 1 VIAL, SINGLE-DOSE (13533-000-06) |
| Grifols Therapeutics Llc | PROLASTIN, PROLASTIN-C | alpha-1-proteinase inhibitor (human) | For Injection | 103174 | BLA | GRIFOLS USA, LLC | 13533-703-10 | 1 KIT in 1 CARTON (13533-703-10) * 20 mL in 1 VIAL, SINGLE-DOSE (13533-702-11) * 20 mL in 1 VIAL, SINGLE-DOSE (13533-200-20) |
| Grifols Therapeutics Llc | PROLASTIN, PROLASTIN-C | alpha-1-proteinase inhibitor (human) | For Injection | 103174 | BLA | GRIFOLS USA, LLC | 13533-705-01 | 1 VIAL in 1 CARTON (13533-705-01) / 20 mL in 1 VIAL (13533-705-11) |
| Grifols Therapeutics Llc | PROLASTIN, PROLASTIN-C | alpha-1-proteinase inhibitor (human) | For Injection | 103174 | BLA | GRIFOLS USA, LLC | 13533-705-31 | 1 VIAL in 1 CARTON (13533-705-31) / 10 mL in 1 VIAL (13533-705-32) |
| Grifols Therapeutics Llc | PROLASTIN, PROLASTIN-C | alpha-1-proteinase inhibitor (human) | For Injection | 103174 | BLA | GRIFOLS USA, LLC | 13533-705-51 | 1 VIAL in 1 CARTON (13533-705-51) / 80 mL in 1 VIAL (13533-705-52) |
| >Applicant | >Tradename | >Biologic Ingredient | >Dosage | >BLA | >NDA/ANDA | >Supplier | >Package Code | >Package |
