Nystatin

Treats candidiasis in the oral cavity. ANDA 62512, held by Pharmobedient. Nystatin.

As of Nov 14, 2026, ANDA 62512 (Nystatin), held by Pharmobedient, was first approved by FDA on Oct 29, 1984, with 8 approved supplements and 0 published complete response letters.

First approved: Oct 29, 1984
Supplements approved: 8
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 9 submissions below

Date	Submission	Status	Documents
Oct 29, 1984	Original application	Approved	None posted

Products

1 strengths and forms

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

All 9 submissions, including labeling and manufacturing supplements


Mar 20, 2002	Supplement 16Manufacturing	Approved	None posted
Jul 11, 1997	Supplement 15Labeling	Approved	None posted
Sep 3, 1996	Supplement 14Labeling	Approved	None posted
Oct 20, 1994	Supplement 13Manufacturing	Approved	None posted
Sep 30, 1994	Supplement 12Manufacturing	Approved	None posted
Mar 11, 1994	Supplement 11Labeling	Approved	None posted
Mar 25, 1992	Supplement 10Manufacturing	Approved	None posted
Jan 10, 1989	Supplement 9Manufacturing	Approved	None posted
Oct 29, 1984	Original application	Approved	None posted

Identifiers

Application: ANDA 62512
Drugs@FDA: Overview at FDA
Company: PharmoBedient

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