RESTORIL (nda018163)- (7.5MG,15MG,22.5MG,30MG)

Generic Name	TEMAZEPAM	Innovator	SPECGX LLC
Dosage	7.5MG,15MG,22.5MG,30MG
ParaIV Filing	Yes	505(b)2 Filing	No
Last Patent Expiry	Expired	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	Restoril™ (temazepam) is indicated for the short-term treatment of insomnia (generally 7 to 10 days).

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
11	0	8

Other Developers

Total Other Developers	2

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
7.5MG	**	**	Down	-	3
15MG	**	**	Down	-	5
22.5MG	**	**	Up	-	3
30MG	**	**	Down	-	5

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	7

Manufacturing Details of RESTORIL