Nystatin

Treats cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other…. ANDA 65183, held by Upsher Smith Labs. Nystatin.

As of Nov 14, 2026, ANDA 65183 (Nystatin), held by Upsher Smith Labs, was first approved by FDA on May 3, 2005, with 1 approved supplement and 0 published complete response letters.

First approved: May 3, 2005
Supplements approved: 1
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Nyamyc (Nystatin Topical Powder, USP) is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other susceptible Candida species. Nyamyc (Nystatin Topical Powder, USP) 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
May 3, 2005	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


Jan 18, 2007	Supplement 8Labeling	Approved	None posted
May 3, 2005	Original application	Approved	None posted

Identifiers

Application: ANDA 65183
Drugs@FDA: Overview at FDA
Company: Upsher-Smith 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