SULAR (nda020356)- (8.5MG,10MG,17MG,20MG,25.5MG,30MG,34MG,40MG)

Generic Name	NISOLDIPINE	Innovator	COVIS
Dosage	8.5MG,10MG,17MG,20MG,25.5MG,30MG,34MG,40MG
ParaIV Filing	Yes	505(b)2 Filing	No
Last Patent Expiry	2008-Jun-08	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	SULAR is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
3	0	3

Other Developers

Total Other Developers	4

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
8.5MG	**	**	-	-	1
10MG	**	**	-	-	-
17MG	**	**	-	-	1
20MG	**	**	-	-	-
25.5MG	**	**	-	-	-
30MG	**	**	-	-	-
34MG	**	**	-	-	1
40MG	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	2

Manufacturing Details of SULAR