RECTIV (nda021359)- (0.4%)

Generic Name	NITROGLYCERIN	Innovator	ABBVIE
Dosage	0.4%
ParaIV Filing	No	505(b)2 Filing	Yes
Last Patent Expiry	2014-May-27	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	2014-Jun-21
GAIN Expiry	None	Drug Complexity	No
Indication	RECTIV is a nitrate vasodilator indicated for the treatment of moderate to severe pain associated with chronic anal fissure.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
1	0	1

Other Developers

Total Other Developers	7

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
0.4%	**	**	Up	-	1

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	1

Manufacturing Details of RECTIV