Nystatin

ANDA 64042, held by Pai Holdings. Nystatin.

As of Nov 14, 2026, ANDA 64042 (Nystatin), held by Pai Holdings, was first approved by FDA on Feb 28, 1994, with 8 approved supplements and 0 published complete response letters.

First approved: Feb 28, 1994
Supplements approved: 8
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 9 submissions below

Date	Submission	Status	Documents
Feb 28, 1994	Original application	Approved	None posted

Products

1 strengths and forms

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

All 9 submissions, including labeling and manufacturing supplements


Oct 22, 1998	Supplement 5Manufacturing	Approved	None posted
Sep 18, 1998	Supplement 7Manufacturing	Approved	None posted
Sep 18, 1998	Supplement 8Labeling	Approved	None posted
Feb 23, 1998	Supplement 6Manufacturing	Approved	None posted
Apr 1, 1997	Supplement 4Labeling	Approved	None posted
Jan 29, 1997	Supplement 3Manufacturing	Approved	None posted
Apr 25, 1996	Supplement 2Manufacturing	Approved	None posted
Nov 1, 1995	Supplement 1Manufacturing	Approved	None posted
Feb 28, 1994	Original application	Approved	None posted

Identifiers

Application: ANDA 64042
Drugs@FDA: Overview at FDA
Company: PAI Holdings LLC

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