Mycostatin

ANDA 60578, held by Delcor Asset Corp. Nystatin.

As of Nov 14, 2026, ANDA 60578 (Mycostatin), held by Delcor Asset Corp, was first approved by FDA on Sep 8, 1964, with 3 approved supplements and 0 published complete response letters.

First approved: Sep 8, 1964
Supplements approved: 3
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Sep 8, 1964	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Mycostatin100,000 UNITS/GM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · powder;topical	Nystatin	Discontinued

All 4 submissions, including labeling and manufacturing supplements


Sep 17, 1998	Supplement 3Labeling	Approved	None posted
Nov 30, 1992	Supplement 6Labeling	Approved	None posted
Jun 19, 1992	Supplement 5Manufacturing	Approved	None posted
Sep 8, 1964	Original application	Approved	None posted

Identifiers

Application: ANDA 60578
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