Nystex

ANDA 62519, held by Savage Labs. Nystatin.

As of Nov 14, 2026, ANDA 62519 (Nystex), held by Savage Labs, was first approved by FDA on Jul 6, 1984, with 6 approved supplements and 0 published complete response letters.

First approved: Jul 6, 1984
Supplements approved: 6
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 7 submissions below

Date	Submission	Status	Documents
Jul 6, 1984	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Nystex100,000 UNITS/ML · suspension;oral	Nystatin	Discontinued

All 7 submissions, including labeling and manufacturing supplements


Sep 24, 1998	Supplement 6Labeling	Approved	None posted
Sep 19, 1995	Supplement 5Manufacturing	Approved	None posted
Mar 10, 1995	Supplement 1Manufacturing	Approved	None posted
Feb 13, 1995	Supplement 4Manufacturing	Approved	None posted
Oct 8, 1993	Supplement 3Labeling	Approved	None posted
Aug 18, 1993	Supplement 2Labeling	Approved	None posted
Jul 6, 1984	Original application	Approved	None posted

Identifiers

Application: ANDA 62519
Drugs@FDA: Overview at FDA
Company: Savage 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