Nystatin

ANDA 62349, held by G And W Labs Inc. Nystatin.

As of Nov 14, 2026, ANDA 62349 (Nystatin), held by G And W Labs Inc, was first approved by FDA on Jul 14, 1982, with 15 approved supplements and 0 published complete response letters.

First approved: Jul 14, 1982
Supplements approved: 15
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 16 submissions below

Date	Submission	Status	Documents
Jul 14, 1982	Original application	Approved	None posted

Products

1 strengths and forms

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

All 16 submissions, including labeling and manufacturing supplements


Oct 17, 2001	Supplement 31Manufacturing	Approved	None posted
Oct 16, 1998	Supplement 30Manufacturing	Approved	None posted
Jun 3, 1997	Supplement 28Labeling	Approved	None posted
May 8, 1997	Supplement 27Manufacturing	Approved	None posted
Apr 15, 1994	Supplement 26Labeling	Approved	None posted
Jan 14, 1994	Supplement 25Manufacturing	Approved	None posted
Jul 8, 1993	Supplement 24Labeling	Approved	None posted
Nov 9, 1992	Supplement 23Manufacturing	Approved	None posted
Jun 16, 1992	Supplement 22Manufacturing	Approved	None posted
Jul 24, 1991	Supplement 17Manufacturing	Approved	None posted
Jun 11, 1991	Supplement 20Manufacturing	Approved	None posted
Sep 28, 1990	Supplement 21Manufacturing	Approved	None posted
May 11, 1990	Supplement 18Labeling	Approved	None posted
Jul 7, 1989	Supplement 15Manufacturing	Approved	None posted
Jan 26, 1989	Supplement 14Manufacturing	Approved	None posted
Jul 14, 1982	Original application	Approved	None posted

Identifiers

Application: ANDA 62349
Drugs@FDA: Overview at FDA
Company: G & W Laboratories

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