Nystatin

Treats cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other…. ANDA 61966, held by Cosette Pharms Nc. Nystatin.

As of Nov 14, 2026, ANDA 61966 (Nystatin), held by Cosette Pharms Nc, was first approved by FDA on May 25, 1976, with 18 approved supplements and 0 published complete response letters.

First approved: May 25, 1976
Supplements approved: 18
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Nystatin Cream, USP is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other susceptible Candida species. This cream 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 19 submissions below

Date	Submission	Status	Documents
May 25, 1976	Original application	Approved	None posted

Products

1 strengths and forms

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

All 19 submissions, including labeling and manufacturing supplements


Aug 30, 2001	Supplement 25Manufacturing	Approved	None posted
Jun 13, 1996	Supplement 24Manufacturing	Approved	None posted
May 4, 1995	Supplement 23Manufacturing	Approved	None posted
May 4, 1995	Supplement 22Manufacturing	Approved	None posted
Dec 3, 1993	Supplement 21Manufacturing	Approved	None posted
Dec 3, 1993	Supplement 20Manufacturing	Approved	None posted
Dec 3, 1993	Supplement 19Manufacturing	Approved	None posted
Dec 3, 1993	Supplement 18Manufacturing	Approved	None posted
Oct 21, 1993	Supplement 15Manufacturing	Approved	None posted
Oct 21, 1993	Supplement 14Manufacturing	Approved	None posted
Oct 21, 1993	Supplement 13Manufacturing	Approved	None posted
Oct 21, 1993	Supplement 12Manufacturing	Approved	None posted
Aug 31, 1993	Supplement 17Manufacturing	Approved	None posted
Aug 31, 1993	Supplement 16Manufacturing	Approved	None posted
Aug 9, 1993	Supplement 10Manufacturing	Approved	None posted
Apr 27, 1993	Supplement 11Labeling	Approved	None posted
Nov 10, 1992	Supplement 8Manufacturing	Approved	None posted
Sep 25, 1992	Supplement 9Labeling	Approved	None posted
May 25, 1976	Original application	Approved	None posted

Identifiers

Application: ANDA 61966
Drugs@FDA: Overview at FDA
Company: Cosette Pharmaceuticals

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