Nystatin

ANDA 62615, held by Odyssey Pharms. Nystatin.

As of Nov 14, 2026, ANDA 62615 (Nystatin), held by Odyssey Pharms, was first approved by FDA on Oct 17, 1985, with 6 approved supplements and 0 published complete response letters.

First approved: Oct 17, 1985
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
Oct 17, 1985	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Nystatin100,000 UNITS · tablet;vaginal	Nystatin	Discontinued

All 7 submissions, including labeling and manufacturing supplements


May 24, 2001	Supplement 7Manufacturing	Approved	None posted
Jul 7, 2000	Supplement 5Manufacturing	Approved	None posted
Oct 5, 1995	Supplement 4Manufacturing	Approved	None posted
May 11, 1994	Supplement 3Manufacturing	Approved	None posted
Dec 9, 1991	Supplement 2Manufacturing	Approved	None posted
Jun 13, 1986	Supplement 1Manufacturing	Approved	None posted
Oct 17, 1985	Original application	Approved	None posted

Identifiers

Application: ANDA 62615
Drugs@FDA: Overview at FDA
Company: Odyssey 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