FORTAMET (nda021574)- (1GM,500MG)

Generic Name	METFORMIN HYDROCHLORIDE	Innovator	ANDRX LABS LLC
Dosage	1GM,500MG
ParaIV Filing	Yes	505(b)2 Filing	Yes
Last Patent Expiry	2021-Mar-17	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	FORTAMET is a biguanide indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
10	0	9

Other Developers

Total Other Developers	11

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
1GM	**	**	-	-	7
500MG	**	**	-	-	7

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	8

Manufacturing Details of FORTAMET