ACCRUFER (nda212320)- (30MG IRON)

Generic Name	FERRIC MALTOL	Innovator	SHIELD TX
Dosage	30MG IRON
ParaIV Filing	No	505(b)2 Filing	Yes
Last Patent Expiry	2035-Oct-23	NCE Excl Expiry	2024-Jul-25
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	ACCRUFERis an iron replacement product indicated for the treatment of iron deficiency in adults.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
0	0	0

Other Developers

Total Other Developers	6

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
30MG IRON	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	0

Manufacturing Details of ACCRUFER