GLUCOTROL XL (nda020329)- (2.5MG,5MG,10MG)

Generic Name	GLIPIZIDE	Innovator	PFIZER
Dosage	2.5MG,5MG,10MG
ParaIV Filing	Yes	505(b)2 Filing	No
Last Patent Expiry	2019-Mar-26	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	GLUCOTROL XL is a sulfonylurea 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
5	0	5

Other Developers

Total Other Developers	9

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
2.5MG	**	**	-	-	4
5MG	**	**	-	-	4
10MG	**	**	-	-	4

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	5

Manufacturing Details of GLUCOTROL XL