Suppliers and packages for biologic ingredient: rabies immune globulin (human)
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Suppliers and packages for biologic ingredient: rabies immune globulin (human)
| Applicant | Tradename | Biologic Ingredient | Dosage | BLA | NDA/ANDA | Supplier | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| Grifols Therapeutics Llc | BAYRAB, HYPERRAB | rabies immune globulin (human) | Injection | 101144 | BLA | GRIFOLS USA, LLC | 13533-318-01 | 1 VIAL in 1 CARTON (13533-318-01) / 1 mL in 1 VIAL (13533-318-10) |
| Grifols Therapeutics Llc | BAYRAB, HYPERRAB | rabies immune globulin (human) | Injection | 101144 | BLA | GRIFOLS USA, LLC | 13533-318-03 | 1 VIAL in 1 CARTON (13533-318-03) / 3 mL in 1 VIAL (13533-318-30) |
| Grifols Therapeutics Llc | BAYRAB, HYPERRAB | rabies immune globulin (human) | Injection | 101144 | BLA | GRIFOLS USA, LLC | 13533-318-05 | 1 VIAL in 1 CARTON (13533-318-05) / 5 mL in 1 VIAL (13533-318-50) |
| Grifols Therapeutics Llc | BAYRAB, HYPERRAB | rabies immune globulin (human) | Injection | 101144 | BLA | GRIFOLS USA, LLC | 13533-618-02 | 1 VIAL, GLASS in 1 CARTON (13533-618-02) / 2 mL in 1 VIAL, GLASS (13533-618-20) |
| Grifols Therapeutics Llc | BAYRAB, HYPERRAB | rabies immune globulin (human) | Injection | 101144 | BLA | GRIFOLS USA, LLC | 13533-618-10 | 1 VIAL in 1 CARTON (13533-618-10) / 10 mL in 1 VIAL (13533-618-11) |
| Sanofi Pasteur Sa | IMOGAM | rabies immune globulin (human) | For Injection | 103932 | BLA | Sanofi Pasteur Inc. | 49281-190-20 | 1 VIAL, SINGLE-DOSE in 1 CARTON (49281-190-20) / 2 mL in 1 VIAL, SINGLE-DOSE (49281-190-58) |
| Kamada Ltd. | KEDRAB | rabies immune globulin (human) | Solution | 125613 | BLA | Kedrion Biopharma Inc. | 76125-150-02 | 1 VIAL, GLASS in 1 BOX (76125-150-02) / 2 mL in 1 VIAL, GLASS (76125-150-03) |
| >Applicant | >Tradename | >Biologic Ingredient | >Dosage | >BLA | >NDA/ANDA | >Supplier | >Package Code | >Package |
