NITROSTAT (nda021134)- (0.3MG,0.4MG,0.6MG)

Generic Name	NITROGLYCERIN	Innovator	VIATRIS
Dosage	0.3MG,0.4MG,0.6MG
ParaIV Filing	Yes	505(b)2 Filing	No
Last Patent Expiry	2018-Sep-16	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	NITROSTAT is a nitrate vasodilator indicated for relief of an attack or prophylaxis of angina pectoris due to coronary artery disease.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
9	0	6

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
0.3MG	**	**	-	-	6
0.4MG	**	**	-	-	6
0.6MG	**	**	-	-	6

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	4

Manufacturing Details of NITROSTAT