Monistat Dual- Pak

NDA 20968, held by Personal Prods. Miconazole Nitrate.

As of Nov 13, 2026, NDA 20968 (Monistat Dual- Pak), held by Personal Prods, was first approved by FDA on Jun 30, 1999, with 3 approved supplements and 0 published complete response letters.

First approved: Jun 30, 1999
Review: Standard
Supplements approved: 3
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Jun 30, 1999	Original applicationNew dosage form · Standard review	Approved	Review Label Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
Monistat Dual- Pak1.2GM;2% · cream, suppository;topical, vaginal	Miconazole Nitrate	Discontinued

All 4 submissions, including labeling and manufacturing supplements


Feb 11, 2014	Supplement 5Manufacturing · Standard review	Approved	None posted
Jul 10, 2013	Supplement 3Manufacturing · Standard review	Approved	None posted
Feb 6, 2013	Supplement 2Manufacturing · Standard review	Approved	None posted
Jun 30, 1999	Original applicationNew dosage form · Standard review	Approved	Review Label Letter

Identifiers

Application: NDA 20968
Drugs@FDA: Overview at FDA
Company: Personal Products Company

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