Suppliers and packages for biologic ingredient: coagulation factor ix (recombinant), fc fusion protein

Suppliers and packages for biologic ingredient: coagulation factor ix (recombinant), fc fusion protein

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

Applicant	Tradename	Biologic Ingredient	Dosage	BLA	NDA/ANDA	Supplier	Package Code	Package
Bioverativ Therapeutics, Inc.	ALPROLIX	coagulation factor ix (recombinant), fc fusion protein	For Injection	125444	BLA	Bioverativ Therapeutics Inc.	71104-911-01	1 KIT in 1 KIT (71104-911-01) * 5 mL in 1 VIAL (71104-953-09) * 5 mL in 1 VIAL (71104-045-01)
Bioverativ Therapeutics, Inc.	ALPROLIX	coagulation factor ix (recombinant), fc fusion protein	For Injection	125444	BLA	Bioverativ Therapeutics Inc.	71104-922-01	1 KIT in 1 KIT (71104-922-01) * 5 mL in 1 VIAL (71104-954-09) * 5 mL in 1 VIAL (71104-045-01)
Bioverativ Therapeutics, Inc.	ALPROLIX	coagulation factor ix (recombinant), fc fusion protein	For Injection	125444	BLA	Bioverativ Therapeutics Inc.	71104-933-01	1 KIT in 1 KIT (71104-933-01) * 5 mL in 1 VIAL (71104-955-09) * 5 mL in 1 VIAL (71104-045-01)
Bioverativ Therapeutics, Inc.	ALPROLIX	coagulation factor ix (recombinant), fc fusion protein	For Injection	125444	BLA	Bioverativ Therapeutics Inc.	71104-944-01	1 KIT in 1 KIT (71104-944-01) * 5 mL in 1 VIAL (71104-956-09) * 5 mL in 1 VIAL (71104-045-01)
Bioverativ Therapeutics, Inc.	ALPROLIX	coagulation factor ix (recombinant), fc fusion protein	For Injection	125444	BLA	Bioverativ Therapeutics Inc.	71104-966-01	1 KIT in 1 CARTON (71104-966-01) * 5 mL in 1 VIAL (71104-952-01) * 5 mL in 1 VIAL (71104-045-01)
Bioverativ Therapeutics, Inc.	ALPROLIX	coagulation factor ix (recombinant), fc fusion protein	For Injection	125444	BLA	Bioverativ Therapeutics Inc.	71104-977-01	1 KIT in 1 CARTON (71104-977-01) * 5 mL in 1 VIAL (71104-951-09) * 5 mL in 1 VIAL (71104-045-01)