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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 074414

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NDA 074414 describes MICONAZOLE NITRATE, which is a drug marketed by Perrigo R And D, Cosette, Perrigo, Sun Pharma Canada, Teva, Teva Pharms, Actavis Pharma, and L Perrigo Co, and is included in twelve NDAs. It is available from twenty-five suppliers. Additional details are available on the MICONAZOLE NITRATE profile page.

The generic ingredient in MICONAZOLE NITRATE 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 074414

Tradename:	MICONAZOLE NITRATE
Applicant:	Cosette
Ingredient:	miconazole nitrate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SUPPOSITORY;VAGINAL			Strength	100MG
Approval Date:	Apr 30, 1997	TE:		RLD:	No

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