Monistat 3 Combination Pack

NDA 20670, held by Medtech Products. Miconazole Nitrate.

As of Nov 14, 2026, NDA 20670 (Monistat 3 Combination Pack), held by Medtech Products, was first approved by FDA on Apr 16, 1996, with 18 approved supplements and 0 published complete response letters.

First approved: Apr 16, 1996
Review: Standard
Supplements approved: 18
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 19 submissions below

Date	Submission	Status	Documents
Apr 16, 1996	Original applicationTYPE 8 · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Monistat 3 Combination Pack2%,200MG · cream, suppository;topical, vaginal	Miconazole Nitrate	OTCReference drug

All 19 submissions, including labeling and manufacturing supplements


Nov 17, 2023	Supplement 41Labeling · Standard review	Approved	Label Letter
Jul 22, 2020	Supplement 36Manufacturing	Approved	Label Letter
Jan 28, 2020	Supplement 35Labeling · Standard review	Approved	Label Letter
Jan 21, 2016	Supplement 29Manufacturing · Standard review	Approved	None posted
Nov 20, 2015	Supplement 28Manufacturing · Standard review	Approved	None posted
Feb 11, 2014	Supplement 24Manufacturing · Standard review	Approved	None posted
Jul 10, 2013	Supplement 22Manufacturing · Standard review	Approved	None posted
Feb 6, 2013	Supplement 21Manufacturing · Standard review	Approved	None posted
Mar 16, 2007	Supplement 14Manufacturing	Approved	Review Letter Label
Jan 9, 2003	Supplement 11Labeling · Standard review	Approved	Letter
Oct 28, 2002	Supplement 10Manufacturing · Standard review	Approved	None posted
Apr 10, 2002	Supplement 9Manufacturing · Standard review	Approved	Review
Jan 20, 2000	Supplement 7Manufacturing · Standard review	Approved	None posted
Oct 4, 1999	Supplement 5Manufacturing · Standard review	Approved	None posted
Mar 26, 1999	Supplement 4Manufacturing · Standard review	Approved	None posted
Mar 17, 1998	Supplement 3Manufacturing · Standard review	Approved	None posted
Mar 21, 1997	Supplement 2Manufacturing · Standard review	Approved	None posted
Aug 15, 1996	Supplement 1Manufacturing · Standard review	Approved	None posted
Apr 16, 1996	Original applicationTYPE 8 · Standard review	Approved	None posted

Identifiers

Application: NDA 20670
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