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Last Updated: March 19, 2026

Details for New Drug Application (NDA): 091366

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NDA 091366 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 091366

Tradename:	MICONAZOLE NITRATE
Applicant:	Perrigo R And D
Ingredient:	miconazole nitrate
Patents:	0

Pharmacology for NDA: 091366

Suppliers and Packaging for NDA: 091366

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
MICONAZOLE NITRATE	miconazole nitrate	CREAM;VAGINAL	091366	ANDA	L. Perrigo Company	0113-7110	0113-7110-14	3 POUCH in 1 CARTON (0113-7110-14) / 1 APPLICATOR in 1 POUCH / 5 g in 1 APPLICATOR
MICONAZOLE NITRATE	miconazole nitrate	CREAM;VAGINAL	091366	ANDA	Walgreen Company	0363-2070	0363-2070-14	3 APPLICATOR in 1 CARTON (0363-2070-14) / 5 g in 1 APPLICATOR

Profile for product number 001

Active Rx/OTC/Discontinued:	OTC	Dosage:	CREAM;VAGINAL			Strength	4%
Approval Date:	Jan 15, 2010	TE:		RLD:	No

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