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Last Updated: April 4, 2026

Details for New Drug Application (NDA): 018592

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NDA 018592 describes MONISTAT 5, which is a drug marketed by Personal Prods and is included in one NDA. Additional details are available on the MONISTAT 5 profile page.

The generic ingredient in MONISTAT 5 is miconazole nitrate. There are twenty-eight drug master file entries for this compound. Forty-six suppliers are listed for this compound. Additional details are available on the miconazole nitrate profile page.

Summary for 018592

Tradename:	MONISTAT 5
Applicant:	Personal Prods
Ingredient:	miconazole nitrate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TAMPON;VAGINAL			Strength	100MG
Approval Date:	Oct 27, 1989	TE:		RLD:	No

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