ONMEL (nda022484)- (200MG)

Generic Name	ITRACONAZOLE	Innovator	SEBELA IRELAND LTD
Dosage	200MG
ParaIV Filing	No	505(b)2 Filing	No
Last Patent Expiry	2028-Oct-03	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	2013-Apr-29
GAIN Expiry	None	Drug Complexity	No
Indication	ONMEL, an azole antifungal, are indicated for the treatment of onychomycosis of the toenail caused by Trichophyton rubrum or T. mentagrophytes.

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
200MG	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	0

Manufacturing Details of ONMEL