VENOFER (nda021135)- (EQ 100MG IRON/5ML (EQ 20MG IRON/ML),EQ 50MG IRON/2.5ML (EQ 20MG IRON/ML),EQ 75MG IRON/3.75ML (EQ 20MG IRON/ML),EQ 200MG IRON/10ML (EQ 20MG IRON/ML),EQ 65MG IRON/3.25ML (EQ 20MG IRON/ML))

Generic Name	FERRIC OXYHYDROXIDE	Innovator	AM REGENT
Dosage	EQ 100MG IRON/5ML (EQ 20MG IRON/ML),EQ 50MG IRON/2.5ML (EQ 20MG IRON/ML),EQ 75MG IRON/3.75ML (EQ 20MG IRON/ML),EQ 200MG IRON/10ML (EQ 20MG IRON/ML),EQ 65MG IRON/3.25ML (EQ 20MG IRON/ML)
ParaIV Filing	No	505(b)2 Filing	No
Last Patent Expiry	Expired	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	Venofer is an iron replacement product indicated for the treatment of iron deficiency anemia (IDA) in patients with chronic kidney disease (CKD).

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
0	0	0

Other Developers

Total Other Developers	42

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
EQ 100MG IRON/5ML (EQ 20MG IRON/ML)	**	**	-	-	-
EQ 50MG IRON/2.5ML (EQ 20MG IRON/ML)	**	**	-	-	-
EQ 75MG IRON/3.75ML (EQ 20MG IRON/ML)	**	**	-	-	-
EQ 200MG IRON/10ML (EQ 20MG IRON/ML)	**	**	-	-	-
EQ 65MG IRON/3.25ML (EQ 20MG IRON/ML)	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	0

Manufacturing Details of VENOFER