Nystatin

ANDA 62517, held by Fougera Pharms Inc. Nystatin.

As of Nov 14, 2026, ANDA 62517 (Nystatin), held by Fougera Pharms Inc, was first approved by FDA on Jun 7, 1984, with 6 approved supplements and 0 published complete response letters.

First approved: Jun 7, 1984
Supplements approved: 6
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 7 submissions below

Date	Submission	Status	Documents
Jun 7, 1984	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Nystatin100,000 UNITS/ML · suspension;oral	Nystatin	Rx

All 7 submissions, including labeling and manufacturing supplements


Dec 14, 2004	Supplement 9Labeling	Approved	None posted
Dec 13, 2004	Supplement 6Labeling	Approved	None posted
Jan 26, 1999	Supplement 5Manufacturing	Approved	None posted
Jun 11, 1998	Supplement 4Labeling	Approved	None posted
Jun 23, 1995	Supplement 3Manufacturing	Approved	None posted
Sep 27, 1993	Supplement 2Labeling	Approved	None posted
Jun 7, 1984	Original application	Approved	None posted

Identifiers

Application: ANDA 62517
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