Nystatin

ANDA 64142, held by Vistapharm LLC. Nystatin.

As of Nov 14, 2026, ANDA 64142 (Nystatin), held by Vistapharm LLC, was first approved by FDA on Jun 25, 1998, with 2 approved supplements and 0 published complete response letters.

First approved: Jun 25, 1998
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Jun 25, 1998	Original application	Approved	Letter Label Review

Products

2 strengths and forms


Nystatin100,000 UNITS/ML · suspension;oral	Nystatin	Discontinued
Nystatin100,000 UNITS/ML · suspension;oral	Nystatin	Discontinued

All 3 submissions, including labeling and manufacturing supplements


Mar 21, 2024	Supplement 22Labeling · Standard review	Approved	None posted
Dec 13, 2001	Supplement 1Manufacturing	Approved	None posted
Jun 25, 1998	Original application	Approved	Letter Label Review

Identifiers

Application: ANDA 64142
Drugs@FDA: Overview at FDA
Company: VistaPharm

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