Nystatin

ANDA 62776, held by Cosette Pharms Nc. Nystatin.

As of Nov 14, 2026, ANDA 62776 (Nystatin), held by Cosette Pharms Nc, was first approved by FDA on Dec 17, 1987, with 25 approved supplements and 0 published complete response letters.

First approved: Dec 17, 1987
Supplements approved: 25
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 26 submissions below

Date	Submission	Status	Documents
Dec 17, 1987	Original application	Approved	None posted

Products

1 strengths and forms

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

All 26 submissions, including labeling and manufacturing supplements


Aug 30, 2001	Supplement 27Manufacturing	Approved	None posted
Aug 19, 1997	Supplement 26Manufacturing	Approved	None posted
Mar 19, 1997	Supplement 25Manufacturing	Approved	None posted
Apr 12, 1996	Supplement 24Manufacturing	Approved	None posted
Jun 26, 1995	Supplement 23Manufacturing	Approved	None posted
Jun 26, 1995	Supplement 22Manufacturing	Approved	None posted
Jun 26, 1995	Supplement 21Manufacturing	Approved	None posted
May 4, 1995	Supplement 20Manufacturing	Approved	None posted
May 4, 1995	Supplement 19Manufacturing	Approved	None posted
Feb 9, 1994	Supplement 6Labeling	Approved	None posted
Dec 3, 1993	Supplement 18Manufacturing	Approved	None posted
Dec 3, 1993	Supplement 17Manufacturing	Approved	None posted
Oct 21, 1993	Supplement 16Manufacturing	Approved	None posted
Oct 21, 1993	Supplement 15Manufacturing	Approved	None posted
Oct 21, 1993	Supplement 14Manufacturing	Approved	None posted
Oct 21, 1993	Supplement 13Manufacturing	Approved	None posted
Oct 21, 1993	Supplement 12Manufacturing	Approved	None posted
Oct 21, 1993	Supplement 11Manufacturing	Approved	None posted
Apr 1, 1993	Supplement 9Manufacturing	Approved	None posted
Mar 31, 1993	Supplement 10Manufacturing	Approved	None posted
Mar 31, 1993	Supplement 8Manufacturing	Approved	None posted
Mar 31, 1993	Supplement 7Manufacturing	Approved	None posted
Jun 1, 1992	Supplement 4Manufacturing	Approved	None posted
May 21, 1992	Supplement 5Labeling	Approved	None posted
Jul 24, 1989	Supplement 3Manufacturing	Approved	None posted
Dec 17, 1987	Original application	Approved	None posted

Identifiers

Application: ANDA 62776
Drugs@FDA: Overview at FDA
Company: Cosette Pharmaceuticals

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