Nilstat

NDA 50576, held by Strides Pharma Intl. Nystatin.

As of Nov 14, 2026, NDA 50576 (Nilstat), held by Strides Pharma Intl, was first approved by FDA on Dec 22, 1983, with 1 approved supplement and 0 published complete response letters.

First approved: Dec 22, 1983
Review: Standard
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Dec 22, 1983	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Nilstat100% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · powder;oral	Nystatin	DiscontinuedReference drug

All 2 submissions, including labeling and manufacturing supplements


May 8, 1999	Supplement 2Manufacturing · Standard review	Approved	None posted
Dec 22, 1983	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 50576
Drugs@FDA: Overview at FDA
Company: Strides Pharma International

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