Nalidixic Acid

ANDA 70270, held by Sun Pharm Industries. Nalidixic Acid.

As of Nov 13, 2026, ANDA 70270 (Nalidixic Acid), held by Sun Pharm Industries, was first approved by FDA on Mar 28, 1986, with 6 approved supplements and 0 published complete response letters.

First approved: Mar 28, 1986
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
Mar 28, 1986	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Nalidixic Acid250MG · tablet;oral	Nalidixic Acid	Discontinued

All 7 submissions, including labeling and manufacturing supplements


Dec 1, 1998	Supplement 10Manufacturing	Approved	None posted
Dec 23, 1994	Supplement 9Manufacturing	Approved	None posted
Oct 11, 1994	Supplement 8Manufacturing	Approved	None posted
Apr 3, 1992	Supplement 5Manufacturing	Approved	None posted
Apr 3, 1992	Supplement 7Manufacturing	Approved	None posted
Feb 9, 1988	Supplement 2Manufacturing	Approved	None posted
Mar 28, 1986	Original application	Approved	None posted

Identifiers

Application: ANDA 70270
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