Suppliers and packages for biologic ingredient: antihemophilic factor (recombinant)

Suppliers and packages for biologic ingredient: antihemophilic factor (recombinant)

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.	BIOCLATE (ARMOUR), RECOMBINATE	antihemophilic factor (recombinant)	For Injection	103375	BLA	Takeda Pharmaceuticals America, Inc.	0944-2841-10	1 KIT in 1 CARTON (0944-2841-10) * 10 mL in 1 VIAL, GLASS (0944-2831-01) * 5 mL in 1 VIAL, GLASS (64764-515-50)
Baxalta Us Inc.	BIOCLATE (ARMOUR), RECOMBINATE	antihemophilic factor (recombinant)	For Injection	103375	BLA	Takeda Pharmaceuticals America, Inc.	0944-2842-10	1 KIT in 1 CARTON (0944-2842-10) * 10 mL in 1 VIAL, GLASS (0944-2832-01) * 5 mL in 1 VIAL, GLASS (64764-515-50)
Baxalta Us Inc.	BIOCLATE (ARMOUR), RECOMBINATE	antihemophilic factor (recombinant)	For Injection	103375	BLA	Takeda Pharmaceuticals America, Inc.	0944-2843-10	1 KIT in 1 CARTON (0944-2843-10) * 10 mL in 1 VIAL, GLASS (0944-2833-01) * 5 mL in 1 VIAL, GLASS (64764-515-50)
Baxalta Us Inc.	BIOCLATE (ARMOUR), RECOMBINATE	antihemophilic factor (recombinant)	For Injection	103375	BLA	Takeda Pharmaceuticals America, Inc.	0944-2844-10	1 KIT in 1 CARTON (0944-2844-10) * 10 mL in 1 VIAL, GLASS (0944-2834-01) * 5 mL in 1 VIAL, GLASS (64764-515-50)
Baxalta Us Inc.	BIOCLATE (ARMOUR), RECOMBINATE	antihemophilic factor (recombinant)	For Injection	103375	BLA	Takeda Pharmaceuticals America, Inc.	0944-2845-10	1 KIT in 1 CARTON (0944-2845-10) * 10 mL in 1 VIAL, GLASS (0944-2835-01) * 5 mL in 1 VIAL, GLASS (64764-515-50)
Novo Nordisk Inc.	NOVOEIGHT	antihemophilic factor (recombinant)	For Injection	125466	BLA	Novo Nordisk	0169-7810-01	1 KIT in 1 KIT (0169-7810-01) * 4 mL in 1 VIAL, GLASS (0169-7811-11) * 4 mL in 1 SYRINGE, GLASS (0169-7008-98)