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
Bayer Healthcare Llc	HELIXATE FS, KOGENATE, KOGENATE FS	antihemophilic factor (recombinant)	For Injection	103332	BLA	Bayer HealthCare LLC	0026-3782-25	1 KIT in 1 BOX (0026-3782-25) * 2.5 mL in 1 VIAL, SINGLE-USE (0026-4782-01) * 2.5 mL in 1 SYRINGE (0026-0426-02)
Bayer Healthcare Llc	HELIXATE FS, KOGENATE, KOGENATE FS	antihemophilic factor (recombinant)	For Injection	103332	BLA	Bayer HealthCare LLC	0026-3783-35	1 KIT in 1 BOX (0026-3783-35) * 2.5 mL in 1 VIAL, SINGLE-USE (0026-4783-01) * 2.5 mL in 1 SYRINGE (0026-0426-02)
Bayer Healthcare Llc	HELIXATE FS, KOGENATE, KOGENATE FS	antihemophilic factor (recombinant)	For Injection	103332	BLA	Bayer HealthCare LLC	0026-3785-55	1 KIT in 1 BOX (0026-3785-55) * 2.5 mL in 1 VIAL, SINGLE-USE (0026-4785-01) * 2.5 mL in 1 SYRINGE (0026-0426-02)
Bayer Healthcare Llc	HELIXATE FS, KOGENATE, KOGENATE FS	antihemophilic factor (recombinant)	For Injection	103332	BLA	Bayer HealthCare LLC	0026-3786-65	1 KIT in 1 BOX (0026-3786-65) * 5 mL in 1 VIAL, SINGLE-USE (0026-4786-01) * 5 mL in 1 SYRINGE (0026-0426-05)
Bayer Healthcare Llc	HELIXATE FS, KOGENATE, KOGENATE FS	antihemophilic factor (recombinant)	For Injection	103332	BLA	Bayer HealthCare LLC	0026-3787-75	1 KIT in 1 BOX (0026-3787-75) * 5 mL in 1 VIAL, SINGLE-USE (0026-4787-01) * 5 mL in 1 SYRINGE (0026-0426-05)
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)