Suppliers and packages for biologic ingredient: hepatitis b immune globulin (human)
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Suppliers and packages for biologic ingredient: hepatitis b immune globulin (human)
| Applicant | Tradename | Biologic Ingredient | Dosage | BLA | NDA/ANDA | Supplier | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| Grifols Therapeutics Llc | BAYHEP B, HYPERHEP B S/D | hepatitis b immune globulin (human) | Injection | 101146 | BLA | GRIFOLS USA, LLC | 13533-636-01 | 1 VIAL, GLASS in 1 CARTON (13533-636-01) / 1 mL in 1 VIAL, GLASS (13533-636-10) |
| Grifols Therapeutics Llc | BAYHEP B, HYPERHEP B S/D | hepatitis b immune globulin (human) | Injection | 101146 | BLA | GRIFOLS USA, LLC | 13533-636-02 | 1 SYRINGE, GLASS in 1 CARTON (13533-636-02) / 1 mL in 1 SYRINGE, GLASS (13533-636-20) |
| Grifols Therapeutics Llc | BAYHEP B, HYPERHEP B S/D | hepatitis b immune globulin (human) | Injection | 101146 | BLA | GRIFOLS USA, LLC | 13533-636-03 | 1 SYRINGE, GLASS in 1 CARTON (13533-636-03) / .5 mL in 1 SYRINGE, GLASS (13533-636-30) |
| Grifols Therapeutics Llc | BAYHEP B, HYPERHEP B S/D | hepatitis b immune globulin (human) | Injection | 101146 | BLA | GRIFOLS USA, LLC | 13533-636-05 | 1 VIAL, GLASS in 1 CARTON (13533-636-05) / 5 mL in 1 VIAL, GLASS (13533-636-50) |
| Adma Biologics, Inc. | NABI-HB | hepatitis b immune globulin (human) | Injection | 103945 | BLA | ADMA Biologics, Inc. | 69800-4202-1 | 1 VIAL, SINGLE-USE in 1 CARTON (69800-4202-1) / 1 mL in 1 VIAL, SINGLE-USE (69800-4202-2) |
| Adma Biologics, Inc. | NABI-HB | hepatitis b immune globulin (human) | Injection | 103945 | BLA | ADMA Biologics, Inc. | 69800-4203-1 | 1 VIAL, SINGLE-USE in 1 CARTON (69800-4203-1) / 5 mL in 1 VIAL, SINGLE-USE (69800-4203-2) |
| >Applicant | >Tradename | >Biologic Ingredient | >Dosage | >BLA | >NDA/ANDA | >Supplier | >Package Code | >Package |
