Gyne-Lotrimin Combination Pack

NDA 20289, held by Bayer Healthcare LLC. Clotrimazole.

As of Nov 13, 2026, NDA 20289 (Gyne-Lotrimin Combination Pack), held by Bayer Healthcare LLC, was first approved by FDA on Apr 26, 1993, with 4 approved supplements and 0 published complete response letters.

First approved: Apr 26, 1993
Review: Standard
Supplements approved: 4
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
Apr 26, 1993	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Gyne-Lotrimin Combination Pack1%,100MG · cream, tablet;topical, vaginal	Clotrimazole	DiscontinuedReference drug

All 5 submissions, including labeling and manufacturing supplements


Feb 22, 2000	Supplement 4Manufacturing · Standard review	Approved	None posted
Dec 9, 1998	Supplement 3Manufacturing · Standard review	Approved	None posted
Mar 17, 1998	Supplement 2Manufacturing · Standard review	Approved	None posted
Mar 6, 1997	Supplement 1Manufacturing · Standard review	Approved	None posted
Apr 26, 1993	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 20289
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