TOVALT ODT (nda021412)- (5MG,10MG)

Generic Name	ZOLPIDEM TARTRATE	Innovator	BIOVAIL LABS INTL
Dosage	5MG,10MG
ParaIV Filing	No	505(b)2 Filing	Yes
Last Patent Expiry	Expired	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	TOVALT ODT (zolpidem tartrate) is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
0	0	0

Other Developers

Total Other Developers	None

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

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

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	0

Manufacturing Details of TOVALT ODT