Mycostatin

ANDA 61533, held by Delcor Asset Corp. Nystatin.

As of Nov 14, 2026, ANDA 61533 (Mycostatin), held by Delcor Asset Corp, was first approved by FDA on Feb 25, 1972, with 9 approved supplements and 0 published complete response letters.

First approved: Feb 25, 1972
Supplements approved: 9
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 10 submissions below

Date	Submission	Status	Documents
Feb 25, 1972	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Mycostatin100,000 UNITS/ML · suspension;oral	Nystatin	Discontinued

All 10 submissions, including labeling and manufacturing supplements


Apr 16, 1996	Supplement 18Labeling	Approved	None posted
Oct 16, 1995	Supplement 19Manufacturing	Approved	None posted
Jan 11, 1994	Supplement 17Manufacturing	Approved	None posted
Dec 7, 1992	Supplement 16Labeling	Approved	None posted
Nov 2, 1992	Supplement 15Labeling	Approved	None posted
Sep 25, 1992	Supplement 11Labeling	Approved	None posted
Jun 19, 1992	Supplement 13Manufacturing	Approved	None posted
Aug 21, 1990	Supplement 10Labeling	Approved	None posted
Mar 29, 1988	Supplement 9Manufacturing	Approved	None posted
Feb 25, 1972	Original application	Approved	None posted

Identifiers

Application: ANDA 61533
Drugs@FDA: Overview at FDA
Company: Delcor Asset Corp.

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