Monistat 7 Combination Pack

NDA 20288, held by Medtech Products. Miconazole Nitrate.

As of Nov 13, 2026, NDA 20288 (Monistat 7 Combination Pack), held by Medtech Products, was first approved by FDA on Apr 26, 1993, with 9 approved supplements and 0 published complete response letters.

First approved: Apr 26, 1993
Review: Standard
Supplements approved: 9
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 10 submissions below

Date	Submission	Status	Documents
Apr 26, 1993	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Monistat 7 Combination Pack2%,100MG · cream, suppository;topical, vaginal	Miconazole Nitrate	OTCReference drug

All 10 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Jul 10, 2013	Supplement 17Manufacturing · Standard review	Approved	None posted
Oct 28, 2002	Supplement 9Manufacturing · Standard review	Approved	None posted
Apr 10, 2002	Supplement 8Manufacturing · Standard review	Approved	None posted
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 26, 1993	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 20288
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