Gyne-Lotrimin

NDA 18052, held by Bayer Healthcare LLC. Clotrimazole.

As of Nov 13, 2026, NDA 18052 (Gyne-Lotrimin), held by Bayer Healthcare LLC, was first approved by FDA on Nov 8, 1978, with 28 approved supplements and 0 published complete response letters.

First approved: Nov 8, 1978
Review: Standard
Supplements approved: 28
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 29 submissions below

Date	Submission	Status	Documents
Apr 26, 1993	Supplement 24Efficacy (new indication or use)	Approved	None posted
Nov 30, 1990	Supplement 12Efficacy (new indication or use)	Approved	None posted
Nov 8, 1978	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Gyne-Lotrimin1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · cream;vaginal	Clotrimazole	DiscontinuedReference drug

All 29 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Apr 12, 2010	Supplement 32Labeling · Standard review	Approved	Label Letter
Jan 16, 2002	Supplement 30Manufacturing · Standard review	Approved	None posted
Feb 2, 2001	Supplement 29Manufacturing · Standard review	Approved	None posted
Sep 1, 2000	Supplement 28Manufacturing · Standard review	Approved	None posted
Jan 20, 2000	Supplement 27Manufacturing · Standard review	Approved	None posted
Dec 9, 1998	Supplement 26Manufacturing · Standard review	Approved	None posted
Aug 11, 1998	Supplement 25Manufacturing · Standard review	Approved	None posted
Sep 22, 1993	Supplement 18Manufacturing · Standard review	Approved	None posted
Apr 26, 1993	Supplement 24Efficacy (new indication or use)	Approved	None posted
Apr 21, 1993	Supplement 21Manufacturing · Standard review	Approved	None posted
Apr 15, 1993	Supplement 23Manufacturing · Standard review	Approved	None posted
Oct 8, 1992	Supplement 22Labeling · Standard review	Approved	None posted
Jun 23, 1992	Supplement 17Manufacturing · Standard review	Approved	None posted
May 12, 1992	Supplement 20Labeling	Approved	None posted
Apr 14, 1992	Supplement 19Labeling	Approved	None posted
Nov 30, 1990	Supplement 12Efficacy (new indication or use)	Approved	None posted
Sep 11, 1990	Supplement 14Manufacturing · Standard review	Approved	None posted
Oct 4, 1988	Supplement 13Manufacturing · Standard review	Approved	None posted
Jun 18, 1987	Supplement 11Manufacturing · Standard review	Approved	None posted
Dec 4, 1986	Supplement 4Labeling	Approved	None posted
Sep 12, 1986	Supplement 10Manufacturing · Standard review	Approved	None posted
May 20, 1986	Supplement 9Manufacturing · Standard review	Approved	None posted
Jul 24, 1985	Supplement 7Manufacturing · Standard review	Approved	None posted
Oct 9, 1981	Supplement 5Manufacturing · Standard review	Approved	None posted
Aug 17, 1981	Supplement 6Manufacturing · Standard review	Approved	None posted
Mar 27, 1981	Supplement 3Manufacturing · Standard review	Approved	None posted
Jan 3, 1980	Supplement 2Manufacturing · Standard review	Approved	None posted
Nov 27, 1979	Supplement 1Labeling	Approved	None posted
Nov 8, 1978	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 18052
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