DEXFERRUM (nda040024)- (EQ 50MG IRON/ML)

Generic Name	FERRIC OXYHYDROXIDE	Innovator	AM REGENT
Dosage	EQ 50MG IRON/ML
ParaIV Filing	No	505(b)2 Filing	No
Last Patent Expiry	2015-Sep-29	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	Dexferrum is indicated for treatment of patients with documented iron deficiency in whom oral administration is unsatisfactory or impossible.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
0	0	0

Other Developers

Total Other Developers	None

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
EQ 50MG IRON/ML	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	0

Manufacturing Details of DEXFERRUM