Suppliers and packages for biologic ingredient: immune globulin intravenous (human)
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Suppliers and packages for biologic ingredient: immune globulin intravenous (human)
| Applicant | Tradename | Biologic Ingredient | Dosage | BLA | NDA/ANDA | Supplier | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| Baxalta Us Inc. | GAMMAGARD, GAMMAGARD S/D, IVEEGAM | immune globulin intravenous (human) | For Injection | 103133 | BLA | Takeda Pharmaceuticals America, Inc. | 0944-2656-03 | 1 KIT in 1 CARTON (0944-2656-03) * 96 mL in 1 BOTTLE (0338-0001-77) * 96 mL in 1 BOTTLE (64764-512-96) * 100 mL in 1 BOTTLE (0944-2657-07) |
| Baxalta Us Inc. | GAMMAGARD, GAMMAGARD S/D, IVEEGAM | immune globulin intravenous (human) | For Injection | 103133 | BLA | Takeda Pharmaceuticals America, Inc. | 0944-2658-04 | 1 KIT in 1 CARTON (0944-2658-04) * 192 mL in 1 BOTTLE (0338-0001-37) * 192 mL in 1 BOTTLE (64764-511-92) * 200 mL in 1 BOTTLE (0944-2659-08) |
| Octapharma Pharmazeutika Produktionsges.m.b.h. | OCTAGAM | immune globulin intravenous (human) | Injection | 125062 | BLA | Pfizer Laboratories Div Pfizer Inc | 0069-6002-02 | 1 BOTTLE, GLASS in 1 CARTON (0069-6002-02) / 20 mL in 1 BOTTLE, GLASS (0069-6002-01) |
| Octapharma Pharmazeutika Produktionsges.m.b.h. | OCTAGAM | immune globulin intravenous (human) | Injection | 125062 | BLA | Pfizer Laboratories Div Pfizer Inc | 0069-6111-02 | 1 BOTTLE, GLASS in 1 CARTON (0069-6111-02) / 100 mL in 1 BOTTLE, GLASS (0069-6111-01) |
| Octapharma Pharmazeutika Produktionsges.m.b.h. | OCTAGAM | immune globulin intravenous (human) | Injection | 125062 | BLA | Pfizer Laboratories Div Pfizer Inc | 0069-6237-02 | 1 BOTTLE, GLASS in 1 CARTON (0069-6237-02) / 200 mL in 1 BOTTLE, GLASS (0069-6237-01) |
| Octapharma Pharmazeutika Produktionsges.m.b.h. | OCTAGAM | immune globulin intravenous (human) | Injection | 125062 | BLA | Pfizer Laboratories Div Pfizer Inc | 0069-6339-02 | 1 BOTTLE, GLASS in 1 CARTON (0069-6339-02) / 300 mL in 1 BOTTLE, GLASS (0069-6339-01) |
| Octapharma Pharmazeutika Produktionsges.m.b.h. | OCTAGAM | immune globulin intravenous (human) | Injection | 125062 | BLA | Pfizer Laboratories Div Pfizer Inc | 0069-6550-02 | 1 BOTTLE, GLASS in 1 CARTON (0069-6550-02) / 50 mL in 1 BOTTLE, GLASS (0069-6550-01) |
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