Nystatin

ANDA 62457, held by Sun Pharma Canada. Nystatin.

As of Nov 14, 2026, ANDA 62457 (Nystatin), held by Sun Pharma Canada, was first approved by FDA on Jul 28, 1983, with 6 approved supplements and 0 published complete response letters.

First approved: Jul 28, 1983
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
Jul 28, 1983	Original application	Approved	None posted

Products

1 strengths and forms

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

All 7 submissions, including labeling and manufacturing supplements


Aug 6, 1993	Supplement 20Labeling	Approved	None posted
Apr 27, 1993	Supplement 21Labeling	Approved	None posted
Apr 29, 1992	Supplement 18Manufacturing	Approved	None posted
Feb 24, 1992	Supplement 17Labeling	Approved	None posted
Jun 30, 1989	Supplement 15Manufacturing	Approved	None posted
Nov 16, 1988	Supplement 7Manufacturing	Approved	None posted
Jul 28, 1983	Original application	Approved	None posted

Identifiers

Application: ANDA 62457
Drugs@FDA: Overview at FDA
Company: Sun Pharma Canada

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