METROGEL (nda019737)- (0.75%)

Generic Name	METRONIDAZOLE	Innovator	GALDERMA LABS LP
Dosage	0.75%
ParaIV Filing	No	505(b)2 Filing	No
Last Patent Expiry	2006-Jun-06	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	METROGEL, 1% is a nitroimidazole indicated for the topical treatment of inflammatory lesions of rosacea.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
4	0	4

Other Developers

Total Other Developers	5

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
0.75%	**	**	-	2	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	4

Manufacturing Details of METROGEL