Suppliers and packages for biologic ingredient: factor ix complex

Suppliers and packages for biologic ingredient: factor ix complex

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

Applicant	Tradename	Biologic Ingredient	Dosage	BLA	NDA/ANDA	Supplier	Package Code	Package
Grifols Biologicals Llc	PROFILNINE, PROFILNINE HP, PROFILNINE HT, PROFILNINE SD	factor ix complex	For Injection	102476	BLA	GRIFOLS USA, LLC	68516-3207-1	1 KIT in 1 CARTON (68516-3207-1) * 5 mL in 1 VIAL (68516-3204-1) * 5 mL in 1 VIAL, SINGLE-DOSE (68516-1001-1)
Grifols Biologicals Llc	PROFILNINE, PROFILNINE HP, PROFILNINE HT, PROFILNINE SD	factor ix complex	For Injection	102476	BLA	GRIFOLS USA, LLC	68516-3208-2	1 KIT in 1 CARTON (68516-3208-2) * 10 mL in 1 VIAL (68516-3205-2) * 10 mL in 1 VIAL, SINGLE-DOSE (68516-1002-2)
Grifols Biologicals Llc	PROFILNINE, PROFILNINE HP, PROFILNINE HT, PROFILNINE SD	factor ix complex	For Injection	102476	BLA	GRIFOLS USA, LLC	68516-3209-2	1 KIT in 1 CARTON (68516-3209-2) * 10 mL in 1 VIAL (68516-3206-2) * 10 mL in 1 VIAL, SINGLE-DOSE (68516-1002-2)
Grifols Biologicals Llc	PROFILNINE, PROFILNINE HP, PROFILNINE HT, PROFILNINE SD	factor ix complex	For Injection	102476	BLA	GRIFOLS USA, LLC	68516-3210-1	1 KIT in 1 CARTON (68516-3210-1) * 5 mL in 1 VIAL (68516-3204-1) * 5 mL in 1 VIAL, GLASS (76297-002-02)
Grifols Biologicals Llc	PROFILNINE, PROFILNINE HP, PROFILNINE HT, PROFILNINE SD	factor ix complex	For Injection	102476	BLA	GRIFOLS USA, LLC	68516-3211-2	1 KIT in 1 CARTON (68516-3211-2) * 10 mL in 1 VIAL (68516-3205-2) * 10 mL in 1 VIAL, GLASS (76297-002-12)
Grifols Biologicals Llc	PROFILNINE, PROFILNINE HP, PROFILNINE HT, PROFILNINE SD	factor ix complex	For Injection	102476	BLA	GRIFOLS USA, LLC	68516-3212-2	1 KIT in 1 CARTON (68516-3212-2) * 10 mL in 1 VIAL, GLASS (76297-002-12) * 10 mL in 1 VIAL (68516-3206-2)