Nystatin

Treats cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other…. ANDA 65203, held by Dr Reddys Labs SA. Nystatin.

As of Nov 14, 2026, ANDA 65203 (Nystatin), held by Dr Reddys Labs SA, was first approved by FDA on Jul 15, 2004, with 1 approved supplement and 0 published complete response letters.

First approved: Jul 15, 2004
Supplements approved: 1
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Nystatin topical powder is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other susceptible Candida species. Nystatin topical powder is not indicated for systemic, oral, intravaginal or ophthalmic use.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Jul 15, 2004	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Nystatin100,000 UNITS/GM · powder;topical	Nystatin	Rx

All 2 submissions, including labeling and manufacturing supplements


Feb 13, 2006	Supplement 4Labeling	Approved	None posted
Jul 15, 2004	Original application	Approved	None posted

Identifiers

Application: ANDA 65203
Drugs@FDA: Overview at FDA
Company: Dr. Reddy's Laboratories

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