Nystatin

ANDA 62613, held by Paddock LLC. Nystatin.

As of Nov 14, 2026, ANDA 62613 (Nystatin), held by Paddock LLC, was first approved by FDA on Nov 26, 1985, with 9 approved supplements and 0 published complete response letters.

First approved: Nov 26, 1985
Supplements approved: 9
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 10 submissions below

Date	Submission	Status	Documents
Nov 26, 1985	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Nystatin100% · powder;oral	Nystatin	Discontinued

All 10 submissions, including labeling and manufacturing supplements


Mar 26, 2002	Supplement 9Manufacturing	Approved	None posted
Dec 27, 1996	Supplement 8Manufacturing	Approved	None posted
Jul 11, 1995	Supplement 7Manufacturing	Approved	None posted
Feb 3, 1995	Supplement 2Labeling	Approved	None posted
Feb 3, 1995	Supplement 1Labeling	Approved	None posted
Oct 18, 1994	Supplement 3Manufacturing	Approved	None posted
Aug 4, 1993	Supplement 5Manufacturing	Approved	None posted
Jul 16, 1993	Supplement 4Manufacturing	Approved	None posted
May 28, 1993	Supplement 6Manufacturing	Approved	None posted
Nov 26, 1985	Original application	Approved	None posted

Identifiers

Application: ANDA 62613
Drugs@FDA: Overview at FDA
Company: Paddock Laboratories

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