Nystatin

ANDA 62838, held by Sun Pharm Industries. Nystatin.

As of Nov 14, 2026, ANDA 62838 (Nystatin), held by Sun Pharm Industries, was first approved by FDA on Dec 22, 1988, with 10 approved supplements and 0 published complete response letters.

First approved: Dec 22, 1988
Supplements approved: 10
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 11 submissions below

Date	Submission	Status	Documents
Dec 22, 1988	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Nystatin500,000 UNITS · tablet;oral	Nystatin	Discontinued

All 11 submissions, including labeling and manufacturing supplements


Jun 28, 2002	Supplement 10Manufacturing	Approved	None posted
Oct 30, 2001	Supplement 9Manufacturing	Approved	None posted
May 16, 2000	Supplement 7Manufacturing	Approved	None posted
May 16, 2000	Supplement 8Manufacturing	Approved	None posted
Jan 30, 1998	Supplement 5Labeling	Approved	None posted
Dec 5, 1997	Supplement 6Manufacturing	Approved	None posted
Feb 24, 1997	Supplement 4Manufacturing	Approved	None posted
Jun 22, 1995	Supplement 3Manufacturing	Approved	None posted
Apr 15, 1994	Supplement 2Labeling	Approved	None posted
Jan 12, 1994	Supplement 1Manufacturing	Approved	None posted
Dec 22, 1988	Original application	Approved	None posted

Identifiers

Application: ANDA 62838
Drugs@FDA: Overview at FDA
Company: Sun Pharmaceutical Industries

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