Tioconazole

ANDA 75915, held by Perrigo. Tioconazole.

As of Nov 14, 2026, ANDA 75915 (Tioconazole), held by Perrigo, was first approved by FDA on Nov 21, 2001, with 4 approved supplements and 0 published complete response letters.

First approved: Nov 21, 2001
Supplements approved: 4
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Use

treats vaginal yeast infections

Full prescribing information on DailyMed ↗

Approvals and New Uses

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

Date	Submission	Status	Documents
Nov 21, 2001	Original application	Approved	Review Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
Tioconazole6.5% · ointment;vaginal	Tioconazole	OTC

All 5 submissions, including labeling and manufacturing supplements


Nov 17, 2015	Supplement 25Labeling · Standard review	Approved	None posted
Apr 30, 2007	Supplement 15Labeling	Approved	None posted
Oct 10, 2003	Supplement 6Labeling	Approved	None posted
Dec 9, 2002	Supplement 2Manufacturing	Approved	None posted
Nov 21, 2001	Original application	Approved	Review Letter

Identifiers

Application: ANDA 75915
Drugs@FDA: Overview at FDA
Company: Perrigo

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