LOTRIMIN ULTRA (nda021307)- (1%)

Generic Name	BUTENAFINE HYDROCHLORIDE	Innovator	BAYER HEALTHCARE LLC
Dosage	1%
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	LOTRIMIN ULTRA is indicated to cure athlete's foot between the toes. Relieves itching, burning, cracking, and scaling which accompany this condition.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
0	0	0

Other Developers

Total Other Developers	4

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
1%	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	0

Manufacturing Details of LOTRIMIN ULTRA