Mycostatin

ANDA 60574, held by Delcor Asset Corp. Nystatin.

As of Nov 14, 2026, ANDA 60574 (Mycostatin), held by Delcor Asset Corp, was first approved by FDA on Sep 16, 1964, with 4 approved supplements and 0 published complete response letters.

First approved: Sep 16, 1964
Supplements approved: 4
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
Sep 16, 1964	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Mycostatin500,000 UNITS · tablet;oral	Nystatin	Discontinued

All 5 submissions, including labeling and manufacturing supplements


Apr 11, 1996	Supplement 13Labeling	Approved	None posted
Nov 27, 1995	Supplement 14Manufacturing	Approved	None posted
Dec 7, 1992	Supplement 12Labeling	Approved	None posted
Jun 23, 1992	Supplement 11Manufacturing	Approved	None posted
Sep 16, 1964	Original application	Approved	None posted

Identifiers

Application: ANDA 60574
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