Monistat 3

NDA 18888, held by Medtech Products. Miconazole Nitrate.

As of Nov 14, 2026, NDA 18888 (Monistat 3), held by Medtech Products, was first approved by FDA on Aug 15, 1984, with 12 approved supplements and 0 published complete response letters.

First approved: Aug 15, 1984
Review: Standard
Supplements approved: 12
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 13 submissions below

Date	Submission	Status	Documents
Aug 15, 1984	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Monistat 3200MG · suppository;vaginal	Miconazole Nitrate	RxReference drug

All 13 submissions, including labeling and manufacturing supplements


Feb 27, 2014	Supplement 18Manufacturing · Standard review	Approved	None posted
Feb 11, 2014	Supplement 17Manufacturing · Standard review	Approved	None posted
Jul 10, 2013	Supplement 15Manufacturing · Standard review	Approved	None posted
Feb 7, 2013	Supplement 14Manufacturing · Standard review	Approved	None posted
Apr 12, 2001	Supplement 10Manufacturing · Standard review	Approved	None posted
Sep 22, 1999	Supplement 9Manufacturing · Standard review	Approved	None posted
Oct 7, 1998	Supplement 7Manufacturing · Standard review	Approved	None posted
Oct 17, 1988	Supplement 6Labeling	Approved	None posted
Sep 17, 1986	Supplement 5Manufacturing · Standard review	Approved	None posted
Apr 25, 1986	Supplement 4Labeling	Approved	None posted
Jul 5, 1985	Supplement 1Manufacturing · Standard review	Approved	None posted
Jun 25, 1985	Supplement 2Manufacturing · Standard review	Approved	None posted
Aug 15, 1984	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 18888
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