MONISTAT 1 COMBINATION PACK (nda021308)- (2%,1.2GM)

Generic Name	MICONAZOLE NITRATE	Innovator	MEDTECH PRODUCTS
Dosage	2%,1.2GM
ParaIV Filing	Yes	505(b)2 Filing	No
Last Patent Expiry	2020-Nov-28	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	MONISTAT 1 COMBINATION PACK is indicated to treat vaginal yeast infections, relieves external itching and irritation due to a vaginal yeast infection.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
1	0	1

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%,1.2GM	**	**	-	-	1

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	1

Manufacturing Details of MONISTAT 1 COMBINATION PACK