Suppliers and packages for biologic ingredient: immune globulin infusion (human), 10% with recombinant human hyaluronidase

Suppliers and packages for biologic ingredient: immune globulin infusion (human), 10% with recombinant human hyaluronidase

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities

Applicant	Tradename	Biologic Ingredient	Dosage	BLA	NDA/ANDA	Supplier	Package Code	Package
Baxalta Us Inc.	HYQVIA	immune globulin infusion (human), 10% with recombinant human hyaluronidase	Injection	125402	BLA	Takeda Pharmaceuticals America, Inc.	0944-2510-02	1 KIT in 1 CARTON (0944-2510-02) * 25 mL in 1 VIAL, GLASS (0944-2715-25) * 1.25 mL in 1 VIAL, GLASS (0944-2720-03)
Baxalta Us Inc.	HYQVIA	immune globulin infusion (human), 10% with recombinant human hyaluronidase	Injection	125402	BLA	Takeda Pharmaceuticals America, Inc.	0944-2511-02	1 KIT in 1 CARTON (0944-2511-02) * 50 mL in 1 VIAL, GLASS (0944-2716-05) * 2.5 mL in 1 VIAL, GLASS (0944-2721-03)
Baxalta Us Inc.	HYQVIA	immune globulin infusion (human), 10% with recombinant human hyaluronidase	Injection	125402	BLA	Takeda Pharmaceuticals America, Inc.	0944-2512-02	1 KIT in 1 CARTON (0944-2512-02) * 100 mL in 1 VIAL, GLASS (0944-2717-10) * 5 mL in 1 VIAL, GLASS (0944-2722-03)
Baxalta Us Inc.	HYQVIA	immune globulin infusion (human), 10% with recombinant human hyaluronidase	Injection	125402	BLA	Takeda Pharmaceuticals America, Inc.	0944-2513-02	1 KIT in 1 CARTON (0944-2513-02) * 10 mL in 1 VIAL, GLASS (0944-2723-03) * 200 mL in 1 VIAL, GLASS (0944-2718-20)
Baxalta Us Inc.	HYQVIA	immune globulin infusion (human), 10% with recombinant human hyaluronidase	Injection	125402	BLA	Takeda Pharmaceuticals America, Inc.	0944-2514-02	1 KIT in 1 CARTON (0944-2514-02) * 300 mL in 1 VIAL, GLASS (0944-2719-30) * 15 mL in 1 VIAL, GLASS (0944-2724-03)