Butoconazole Nitrate

NDA 19881, held by Padagis US. Butoconazole Nitrate.

As of Nov 14, 2026, NDA 19881 (Butoconazole Nitrate), held by Padagis US, was first approved by FDA on Feb 7, 1997, with 7 approved supplements and 0 published complete response letters.

First approved: Feb 7, 1997
Review: Standard
Supplements approved: 7
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below

Date	Submission	Status	Documents
Feb 7, 1997	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Butoconazole Nitrate2% · cream;vaginal	Butoconazole Nitrate	Discontinued

All 8 submissions, including labeling and manufacturing supplements


Aug 10, 2012	Supplement 18Manufacturing · Standard review	Approved	None posted
Jul 24, 2003	Supplement 9Labeling · Standard review	Approved	Letter Label
Apr 30, 2003	Supplement 2Labeling · Standard review	Approved	Letter Label
Aug 2, 2002	Supplement 8Manufacturing · Standard review	Approved	None posted
Sep 28, 2000	Supplement 6Manufacturing · Standard review	Approved	None posted
May 1, 2000	Supplement 5Manufacturing · Standard review	Approved	None posted
Apr 12, 2000	Supplement 4Manufacturing · Standard review	Approved	None posted
Feb 7, 1997	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 19881
Drugs@FDA: Overview at FDA
Company: Padagis US LLC

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