Suppliers and packages for biologic ingredient: immune globulin infusion (human)
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Suppliers and packages for biologic ingredient: immune globulin infusion (human)
| Applicant | Tradename | Biologic Ingredient | Dosage | BLA | NDA/ANDA | Supplier | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| Baxalta Us Inc. | GAMMAGARD LIQUID | immune globulin infusion (human) | Injection | 125105 | BLA | Takeda Pharmaceuticals America, Inc. | 0944-2700-02 | 1 BOTTLE, GLASS in 1 CARTON (0944-2700-02) / 10 mL in 1 BOTTLE, GLASS (0944-2700-08) |
| Baxalta Us Inc. | GAMMAGARD LIQUID | immune globulin infusion (human) | Injection | 125105 | BLA | Takeda Pharmaceuticals America, Inc. | 0944-2700-03 | 1 BOTTLE, GLASS in 1 CARTON (0944-2700-03) / 25 mL in 1 BOTTLE, GLASS (0944-2700-09) |
| Baxalta Us Inc. | GAMMAGARD LIQUID | immune globulin infusion (human) | Injection | 125105 | BLA | Takeda Pharmaceuticals America, Inc. | 0944-2700-04 | 1 BOTTLE, GLASS in 1 CARTON (0944-2700-04) / 50 mL in 1 BOTTLE, GLASS (0944-2700-10) |
| Baxalta Us Inc. | GAMMAGARD LIQUID | immune globulin infusion (human) | Injection | 125105 | BLA | Takeda Pharmaceuticals America, Inc. | 0944-2700-05 | 1 BOTTLE, GLASS in 1 CARTON (0944-2700-05) / 100 mL in 1 BOTTLE, GLASS (0944-2700-11) |
| Baxalta Us Inc. | GAMMAGARD LIQUID | immune globulin infusion (human) | Injection | 125105 | BLA | Takeda Pharmaceuticals America, Inc. | 0944-2700-06 | 1 BOTTLE, GLASS in 1 CARTON (0944-2700-06) / 200 mL in 1 BOTTLE, GLASS (0944-2700-12) |
| Baxalta Us Inc. | GAMMAGARD LIQUID | immune globulin infusion (human) | Injection | 125105 | BLA | Takeda Pharmaceuticals America, Inc. | 0944-2700-07 | 1 BOTTLE, GLASS in 1 CARTON (0944-2700-07) / 300 mL in 1 BOTTLE, GLASS (0944-2700-13) |
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