Nystatin

ANDA 62129, held by Fougera Pharms. Nystatin.

As of Nov 14, 2026, ANDA 62129 (Nystatin), held by Fougera Pharms, was first approved by FDA on Feb 1, 1979, with 5 approved supplements and 0 published complete response letters.

First approved: Feb 1, 1979
Supplements approved: 5
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
Feb 1, 1979	Original application	Approved	None posted

Products

1 strengths and forms

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

All 6 submissions, including labeling and manufacturing supplements


Feb 3, 2016	Supplement 10Labeling · Standard review	Approved	None posted
Sep 19, 2002	Supplement 4Manufacturing	Approved	None posted
Mar 8, 2002	Supplement 5Manufacturing	Approved	None posted
Mar 7, 1996	Supplement 2Manufacturing	Approved	None posted
Jul 5, 1995	Supplement 1Manufacturing	Approved	None posted
Feb 1, 1979	Original application	Approved	None posted

Identifiers

Application: ANDA 62129
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