Nalidixic Acid

ANDA 71919, held by Watson Labs. Nalidixic Acid.

As of Nov 13, 2026, ANDA 71919 (Nalidixic Acid), held by Watson Labs, was first approved by FDA on Jun 28, 1988, with 5 approved supplements and 0 published complete response letters.

First approved: Jun 28, 1988
Supplements approved: 5
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
Jun 28, 1988	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Nalidixic Acid1GM · tablet;oral	Nalidixic Acid	Discontinued

All 6 submissions, including labeling and manufacturing supplements


May 20, 1996	Supplement 6Labeling	Approved	None posted
Jul 31, 1991	Supplement 2Manufacturing	Approved	None posted
Jul 31, 1991	Supplement 3Manufacturing	Approved	None posted
Jan 28, 1991	Supplement 5Manufacturing	Approved	None posted
Jun 29, 1990	Supplement 1Manufacturing	Approved	None posted
Jun 28, 1988	Original application	Approved	None posted

Identifiers

Application: ANDA 71919
Drugs@FDA: Overview at FDA
Company: Watson Laboratories

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