Nystatin

Treats candidiasis in the oral cavity. ANDA 62832, held by Sciegen Pharms. Nystatin.

As of Nov 14, 2026, ANDA 62832 (Nystatin), held by Sciegen Pharms, was first approved by FDA on Dec 27, 1991, with 7 approved supplements and 0 published complete response letters.

First approved: Dec 27, 1991
Supplements approved: 7
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Nystatin Oral Suspension is indicated for the treatment of candidiasis in the oral cavity.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below

Date	Submission	Status	Documents
Dec 27, 1991	Original application	Approved	None posted

Products

1 strengths and forms

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

All 8 submissions, including labeling and manufacturing supplements


Feb 11, 1999	Supplement 8Manufacturing	Approved	None posted
Jul 22, 1997	Supplement 6Labeling	Approved	None posted
Aug 28, 1996	Supplement 5Manufacturing	Approved	None posted
Nov 10, 1994	Supplement 4Manufacturing	Approved	None posted
Nov 10, 1994	Supplement 3Manufacturing	Approved	None posted
Jul 20, 1993	Supplement 1Manufacturing	Approved	None posted
May 28, 1993	Supplement 2Manufacturing	Approved	None posted
Dec 27, 1991	Original application	Approved	None posted

Identifiers

Application: ANDA 62832
Drugs@FDA: Overview at FDA
Company: ScieGen Pharmaceuticals

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