Mycelex

NDA 18183, held by Bayer Healthcare LLC. Clotrimazole.

As of Nov 13, 2026, NDA 18183 (Mycelex), held by Bayer Healthcare LLC, was first approved by FDA on Jan 15, 1979, with 14 approved supplements and 0 published complete response letters.

First approved: Jan 15, 1979
Review: Standard
Supplements approved: 14
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 15 submissions below

Date	Submission	Status	Documents
Jan 15, 1979	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Mycelex1% · cream;topical	Clotrimazole	Discontinued

All 15 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Aug 29, 2001	Supplement 19Manufacturing · Standard review	Approved	None posted
Aug 29, 2001	Supplement 21Manufacturing · Standard review	Approved	None posted
Sep 21, 2000	Supplement 20Manufacturing · Standard review	Approved	None posted
Aug 6, 1999	Supplement 16Manufacturing · Standard review	Approved	None posted
Aug 6, 1999	Supplement 17Manufacturing · Standard review	Approved	None posted
Aug 6, 1999	Supplement 18Manufacturing · Standard review	Approved	None posted
Aug 15, 1996	Supplement 15Manufacturing · Standard review	Approved	None posted
Jun 3, 1996	Supplement 14Labeling	Approved	None posted
Apr 3, 1995	Supplement 13Labeling	Approved	None posted
May 12, 1993	Supplement 12Manufacturing · Standard review	Approved	None posted
Jan 29, 1993	Supplement 11Manufacturing · Standard review	Approved	None posted
Aug 7, 1992	Supplement 10Manufacturing · Standard review	Approved	None posted
Apr 1, 1991	Supplement 8Labeling	Approved	None posted
Mar 29, 1991	Supplement 9Labeling	Approved	None posted
Jan 15, 1979	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 18183
Drugs@FDA: Overview at FDA
Company: Bayer Healthcare

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