Suppliers and packages for biologic ingredient: c1 esterase inhibitor (human)
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Suppliers and packages for biologic ingredient: c1 esterase inhibitor (human)
| Applicant | Tradename | Biologic Ingredient | Dosage | BLA | NDA/ANDA | Supplier | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| Viropharma Biologics Llc | CINRYZE | c1 esterase inhibitor (human) | For Injection | 125267 | BLA | Takeda Pharmaceuticals America, Inc. | 42227-081-05 | 1 VIAL, SINGLE-USE in 1 CARTON (42227-081-05) / 5 mL in 1 VIAL, SINGLE-USE (42227-081-01) |
| Viropharma Biologics Llc | CINRYZE | c1 esterase inhibitor (human) | For Injection | 125267 | BLA | Takeda Pharmaceuticals America, Inc. | 42227-083-01 | 1 KIT in 1 CARTON (42227-083-01) * 5 mL in 1 VIAL, SINGLE-USE (42227-081-01) * 5 mL in 1 VIAL, GLASS (64764-515-50) |
| Csl Behring Gmbh | BERINERT | c1 esterase inhibitor (human) | For Injection | 125287 | BLA | CSL Behring GmbH | 63833-825-02 | 1 KIT in 1 CARTON (63833-825-02) * 10 mL in 1 VIAL (63833-835-01) * 10 mL in 1 VIAL (63833-765-15) |
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