Mycelex

NDA 18713, held by Bayer Hlthcare. Clotrimazole.

As of Nov 13, 2026, NDA 18713 (Mycelex), held by Bayer Hlthcare, was first approved by FDA on Jun 17, 1983, with 15 approved supplements and 0 published complete response letters.

First approved: Jun 17, 1983
Review: Standard
Supplements approved: 15
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 16 submissions below


Sep 29, 1992	Supplement 7Efficacy (new indication or use)	Approved	None posted
Jun 17, 1983	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Mycelex10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · troche/lozenge;oral	Clotrimazole	DiscontinuedReference drug

All 16 submissions, including labeling and manufacturing supplements


Dec 15, 2002	Supplement 19Labeling · Standard review	Approved	Label Letter
Mar 26, 2001	Supplement 17Manufacturing · Standard review	Approved	Review
Jan 23, 2001	Supplement 16Manufacturing · Standard review	Approved	None posted
Oct 7, 1999	Supplement 14Manufacturing · Standard review	Approved	Review
Jun 30, 1999	Supplement 13Manufacturing · Standard review	Approved	None posted
Sep 29, 1992	Supplement 7Efficacy (new indication or use)	Approved	None posted
Dec 30, 1991	Supplement 11Labeling	Approved	None posted
Jan 18, 1990	Supplement 10Manufacturing · Standard review	Approved	None posted
Sep 15, 1989	Supplement 9Manufacturing · Standard review	Approved	None posted
Dec 7, 1988	Supplement 8Manufacturing · Standard review	Approved	None posted
Jan 27, 1988	Supplement 5Manufacturing · Standard review	Approved	None posted
Jan 15, 1988	Supplement 6Manufacturing · Standard review	Approved	None posted
Jun 3, 1987	Supplement 4Manufacturing · Standard review	Approved	Review
Sep 11, 1985	Supplement 2Labeling	Approved	None posted
Nov 13, 1984	Supplement 1Manufacturing · Standard review	Approved	None posted
Jun 17, 1983	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 18713
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