Monistat 3 Combination Pack (Prefilled), Monistat 3 Combination Pack

NDA 21261, held by Medtech Products. Miconazole Nitrate.

As of Nov 15, 2026, NDA 21261 (Monistat 3 Combination Pack (Prefilled), Monistat 3 Combination Pack), held by Medtech Products, was first approved by FDA on Feb 2, 2001, with 13 approved supplements and 0 published complete response letters.

First approved: Feb 2, 2001
Review: Standard
Supplements approved: 13
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Uses treats vaginal yeast infections relieves external itching and irritation due to a vaginal yeast infection

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 14 submissions below

Date	Submission	Status	Documents
Feb 2, 2001	Original applicationNew combination · Standard review	Approved	Review Letter Label

Products

2 strengths and forms


Monistat 3 Combination Pack (Prefilled)2%,4% · cream;topical, vaginal	Miconazole Nitrate	OTCReference drug
Monistat 3 Combination Pack2%,4% · cream;topical, vaginal	Miconazole Nitrate	OTCReference drug

All 14 submissions, including labeling and manufacturing supplements


Jul 22, 2020	Supplement 25Manufacturing	Approved	Label Letter
Jan 28, 2020	Supplement 24Labeling · Standard review	Approved	Label Letter
Mar 10, 2014	Supplement 18Manufacturing · Standard review	Approved	None posted
Feb 27, 2014	Supplement 17Manufacturing · Standard review	Approved	None posted
Feb 11, 2014	Supplement 16Manufacturing · Standard review	Approved	None posted
Jul 10, 2013	Supplement 14Manufacturing · Standard review	Approved	None posted
Jan 29, 2013	Supplement 13Manufacturing · Standard review	Approved	None posted
Dec 21, 2009	Supplement 9Manufacturing	Approved	Label
Oct 28, 2008	Supplement 7Manufacturing · Standard review	Approved	Letter
Jun 17, 2003	Supplement 4Labeling · Standard review	Approved	Letter
Oct 28, 2002	Supplement 3Manufacturing · Standard review	Approved	None posted
Apr 10, 2002	Supplement 2Manufacturing · Standard review	Approved	None posted
Nov 28, 2001	Supplement 1Manufacturing · Standard review	Approved	None posted
Feb 2, 2001	Original applicationNew combination · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 21261
Drugs@FDA: Overview at FDA
Company: Medtech Products

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters