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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 076585

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NDA 076585 describes MICONAZOLE 7 COMBINATION PACK, which is a drug marketed by Cosette and is included in one NDA. Additional details are available on the MICONAZOLE 7 COMBINATION PACK profile page.

The generic ingredient in MICONAZOLE 7 COMBINATION PACK is miconazole nitrate. There are twenty-eight drug master file entries for this compound. Forty-five suppliers are listed for this compound. Additional details are available on the miconazole nitrate profile page.

Summary for 076585

Tradename:	MICONAZOLE 7 COMBINATION PACK
Applicant:	Cosette
Ingredient:	miconazole nitrate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CREAM, SUPPOSITORY;TOPICAL, VAGINAL			Strength	2%,100MG
Approval Date:	Mar 26, 2004	TE:		RLD:	No

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