Suppliers and packages for biologic ingredient: rho(d) immune globulin (human)
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Suppliers and packages for biologic ingredient: rho(d) immune globulin (human)
| Applicant | Tradename | Biologic Ingredient | Dosage | BLA | NDA/ANDA | Supplier | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| Grifols Therapeutics Llc | BAYRHO-D, HYPRHO-D, HYPERRHO S/D FULL DOSE, HYPERRHO S/D MINI-DOSE | rho(d) immune globulin (human) | Injection | 101141 | BLA | GRIFOLS USA, LLC | 13533-631-02 | 1 SYRINGE in 1 CARTON (13533-631-02) / 1 SOLUTION in 1 SYRINGE (13533-631-20) |
| Grifols Therapeutics Llc | BAYRHO-D, HYPRHO-D, HYPERRHO S/D FULL DOSE, HYPERRHO S/D MINI-DOSE | rho(d) immune globulin (human) | Injection | 101141 | BLA | GRIFOLS USA, LLC | 13533-631-11 | 10 CARTON in 1 CARTON (13533-631-11) / 1 SYRINGE in 1 CARTON (13533-631-03) / 1 SOLUTION in 1 SYRINGE (13533-631-20) |
| Grifols Therapeutics Llc | BAYRHO-D, HYPRHO-D, HYPERRHO S/D FULL DOSE, HYPERRHO S/D MINI-DOSE | rho(d) immune globulin (human) | Injection | 101141 | BLA | GRIFOLS USA, LLC | 13533-661-06 | 10 SYRINGE in 1 CARTON (13533-661-06) / 1 SOLUTION in 1 SYRINGE (13533-661-60) |
| Kedrion Biopharma Inc. | MICRHOGAM, RHOGAM | rho(d) immune globulin (human) | Injection | 103777 | BLA | Kedrion Biopharma Inc | 0562-7805-01 | 1 POUCH in 1 CARTON (0562-7805-01) / 1 INJECTION, SOLUTION in 1 POUCH (0562-7805-00) |
| Kedrion Biopharma Inc. | MICRHOGAM, RHOGAM | rho(d) immune globulin (human) | Injection | 103777 | BLA | Kedrion Biopharma Inc | 0562-7805-05 | 5 POUCH in 1 CARTON (0562-7805-05) / 1 INJECTION, SOLUTION in 1 POUCH (0562-7805-00) |
| Kedrion Biopharma Inc. | MICRHOGAM, RHOGAM | rho(d) immune globulin (human) | Injection | 103777 | BLA | Kedrion Biopharma Inc | 0562-7805-25 | 25 POUCH in 1 CARTON (0562-7805-25) / 1 INJECTION, SOLUTION in 1 POUCH (0562-7805-00) |
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