Monistat 3

NDA 20827, held by Medtech Products. Miconazole Nitrate.

As of Nov 15, 2026, NDA 20827 (Monistat 3), held by Medtech Products, was first approved by FDA on Mar 30, 1998, with 18 approved supplements and 0 published complete response letters.

First approved: Mar 30, 1998
Review: Standard
Supplements approved: 18
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Use treats vaginal yeast infections

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 19 submissions below

Date	Submission	Status	Documents
Mar 30, 1998	Original applicationNew dosage form · Standard review	Approved	Label Letter Review

Products

1 strengths and forms

Product	Active ingredient	Marketing
Monistat 34% · cream;vaginal	Miconazole Nitrate	OTCReference drug

All 19 submissions, including labeling and manufacturing supplements


Sep 15, 2021	Supplement 33Manufacturing	Approved	Letter
Jan 28, 2020	Supplement 31Labeling · Standard review	Approved	Label Letter
Mar 10, 2014	Supplement 25Manufacturing · Standard review	Approved	None posted
Feb 27, 2014	Supplement 24Manufacturing · Standard review	Approved	None posted
Feb 11, 2014	Supplement 23Manufacturing · Standard review	Approved	None posted
Jul 10, 2013	Supplement 21Manufacturing · Standard review	Approved	None posted
Jan 29, 2013	Supplement 20Manufacturing · Standard review	Approved	None posted
Oct 2, 2009	Supplement 14Manufacturing	Approved	Label Letter
Sep 5, 2008	Supplement 13Manufacturing	Approved	Letter
Oct 28, 2002	Supplement 10Manufacturing · Standard review	Approved	None posted
Aug 7, 2002	Supplement 6Labeling · Standard review	Approved	Letter
Apr 10, 2002	Supplement 9Manufacturing · Standard review	Approved	None posted
Nov 28, 2001	Supplement 8Manufacturing · Standard review	Approved	None posted
Oct 17, 2000	Supplement 7Manufacturing · Standard review	Approved	None posted
Mar 26, 1999	Supplement 4Manufacturing · Standard review	Approved	None posted
Oct 30, 1998	Supplement 3Manufacturing · Standard review	Approved	None posted
Oct 6, 1998	Supplement 1Manufacturing · Standard review	Approved	None posted
Jul 27, 1998	Supplement 2Manufacturing · Standard review	Approved	None posted
Mar 30, 1998	Original applicationNew dosage form · Standard review	Approved	Label Letter Review

Identifiers

Application: NDA 20827
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