Femstat 3

NDA 20421, held by Bayer. Butoconazole Nitrate.

As of Nov 14, 2026, NDA 20421 (Femstat 3), held by Bayer, was first approved by FDA on Dec 21, 1995, with 2 approved supplements and 0 published complete response letters.

First approved: Dec 21, 1995
Review: Standard
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Dec 21, 1995	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Femstat 32% · cream;vaginal	Butoconazole Nitrate	DiscontinuedReference drug

All 3 submissions, including labeling and manufacturing supplements


Jan 14, 1997	Supplement 2Manufacturing · Standard review	Approved	None posted
Jun 6, 1996	Supplement 1Manufacturing · Standard review	Approved	None posted
Dec 21, 1995	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 20421
Drugs@FDA: Overview at FDA
Company: Bayer

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