Monistat

NDA 18040, held by Janssen Pharma. Miconazole.

As of Nov 13, 2026, NDA 18040 (Monistat), held by Janssen Pharma, was first approved by FDA on Oct 4, 1978, with 6 approved supplements and 0 published complete response letters.

First approved: Oct 4, 1978
Review: Priority
Supplements approved: 6
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 7 submissions below

Date	Submission	Status	Documents
Oct 4, 1978	Original applicationNew dosage form · Priority review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Monistat10MG/ML · injectable;injection	Miconazole	Discontinued

All 7 submissions, including labeling and manufacturing supplements


Jun 25, 1997	Supplement 4Labeling	Approved	None posted
Jul 8, 1993	Supplement 13Labeling	Approved	None posted
Mar 9, 1990	Supplement 9Labeling	Approved	None posted
Apr 20, 1982	Supplement 5Labeling	Approved	None posted
Mar 8, 1979	Supplement 2Labeling	Approved	None posted
Nov 20, 1978	Supplement 1Labeling	Approved	None posted
Oct 4, 1978	Original applicationNew dosage form · Priority review	Approved	None posted

Identifiers

Application: NDA 18040
Drugs@FDA: Overview at FDA
Company: Janssen Pharmaceuticals, Inc.

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