ORAVIG (nda022404)- (50MG)

Generic Name	MICONAZOLE	Innovator	GALT PHARMS
Dosage	50MG
ParaIV Filing	No	505(b)2 Filing	Yes
Last Patent Expiry	2026-Jan-08	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	ORAVIG is an azole antifungal indicated for the local treatment of oropharyngeal candidiasis in adults.

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
50MG	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	0

Manufacturing Details of ORAVIG