Nystatin

ANDA 62124, held by Fougera Pharms. Nystatin.

As of Nov 14, 2026, ANDA 62124 (Nystatin), held by Fougera Pharms, was first approved by FDA on Sep 23, 1982, with 8 approved supplements and 0 published complete response letters.

First approved: Sep 23, 1982
Supplements approved: 8
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 9 submissions below

Date	Submission	Status	Documents
Sep 23, 1982	Original application	Approved	None posted

Products

1 strengths and forms

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

All 9 submissions, including labeling and manufacturing supplements


Sep 19, 2002	Supplement 7Manufacturing	Approved	None posted
Dec 6, 2001	Supplement 8Manufacturing	Approved	None posted
Mar 25, 1996	Supplement 5Manufacturing	Approved	None posted
Mar 7, 1996	Supplement 6Manufacturing	Approved	None posted
Mar 11, 1994	Supplement 2Labeling	Approved	None posted
Mar 11, 1994	Supplement 1Manufacturing	Approved	None posted
Jan 6, 1994	Supplement 4Labeling	Approved	None posted
Jun 3, 1993	Supplement 3Labeling	Approved	None posted
Sep 23, 1982	Original application	Approved	None posted

Identifiers

Application: ANDA 62124
Drugs@FDA: Overview at FDA
Company: Fougera Pharmaceuticals Inc.

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