Mycostatin

ANDA 60575, held by Delcor Asset Corp. Nystatin.

As of Nov 14, 2026, ANDA 60575 (Mycostatin), held by Delcor Asset Corp, was first approved by FDA on Feb 9, 1965, with 5 approved supplements and 0 published complete response letters.

First approved: Feb 9, 1965
Supplements approved: 5
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
Feb 9, 1965	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Mycostatin100,000 UNITS/GM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · cream;topical	Nystatin	Discontinued

All 6 submissions, including labeling and manufacturing supplements


Sep 17, 1998	Supplement 8Labeling	Approved	None posted
Mar 16, 1993	Supplement 12Labeling	Approved	None posted
Mar 23, 1992	Supplement 10Manufacturing	Approved	None posted
Sep 11, 1991	Supplement 11Manufacturing	Approved	None posted
Jun 28, 1990	Supplement 9Manufacturing	Approved	None posted
Feb 9, 1965	Original application	Approved	None posted

Identifiers

Application: ANDA 60575
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