Nystatin

ANDA 62949, held by Actavis Mid Atlantic. Nystatin.

As of Nov 14, 2026, ANDA 62949 (Nystatin), held by Actavis Mid Atlantic, was first approved by FDA on Jun 13, 1988, with 10 approved supplements and 0 published complete response letters.

First approved: Jun 13, 1988
Supplements approved: 10
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 11 submissions below

Date	Submission	Status	Documents
Jun 13, 1988	Original application	Approved	None posted

Products

1 strengths and forms

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

All 11 submissions, including labeling and manufacturing supplements


Oct 3, 2002	Supplement 10Manufacturing	Approved	None posted
Oct 15, 2001	Supplement 6Manufacturing	Approved	None posted
May 30, 2001	Supplement 9Manufacturing	Approved	None posted
Nov 15, 2000	Supplement 8Manufacturing	Approved	None posted
Jan 24, 2000	Supplement 7Manufacturing	Approved	None posted
Jun 1, 1998	Supplement 5Manufacturing	Approved	None posted
Aug 26, 1996	Supplement 4Manufacturing	Approved	None posted
Jul 5, 1995	Supplement 3Manufacturing	Approved	None posted
Jul 5, 1994	Supplement 1Manufacturing	Approved	None posted
Jul 5, 1994	Supplement 2Labeling	Approved	None posted
Jun 13, 1988	Original application	Approved	None posted

Identifiers

Application: ANDA 62949
Drugs@FDA: Overview at FDA
Company: Actavis Mid Atlantic 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