BUTOCONAZOLE NITRATE (nda019881)- (2%)

Generic Name	BUTOCONAZOLE NITRATE	Innovator	PADAGIS US
Dosage	2%
ParaIV Filing	Yes	505(b)2 Filing	No
Last Patent Expiry	2017-Nov-17	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	Butoconazole nitrate vaginal cream, 2% is indicated for the local treatment of vulvovaginal candidiasis (infections caused by Candida).

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
2%	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	0

Manufacturing Details of BUTOCONAZOLE NITRATE