GYNE-LOTRIMIN COMBINATION PACK (nda020289)- (1%,100MG)

Generic Name	CLOTRIMAZOLE	Innovator	BAYER HEALTHCARE LLC
Dosage	1%,100MG
ParaIV Filing	No	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	GYNE-LOTRIMIN COMBINATION PACK® is indicated for the local treatment of candidiasis.

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
1%,100MG	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	0

Manufacturing Details of GYNE-LOTRIMIN COMBINATION PACK