Isoniazid

ANDA 80521, held by Watson Labs. Isoniazid.

As of Nov 14, 2026, ANDA 80521 (Isoniazid), held by Watson Labs, was first approved by FDA on Feb 28, 1972, with 9 approved supplements and 0 published complete response letters.

First approved: Feb 28, 1972
Supplements approved: 9
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 10 submissions below

Date	Submission	Status	Documents
Feb 28, 1972	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Isoniazid300MG · tablet;oral	Isoniazid	Discontinued

All 10 submissions, including labeling and manufacturing supplements


Apr 3, 1998	Supplement 43Manufacturing	Approved	None posted
Aug 18, 1997	Supplement 42Labeling	Approved	None posted
Jan 26, 1993	Supplement 41Manufacturing	Approved	None posted
Dec 1, 1992	Supplement 40Labeling	Approved	None posted
Dec 23, 1991	Supplement 37Manufacturing	Approved	None posted
Dec 23, 1991	Supplement 36Manufacturing	Approved	None posted
Nov 19, 1990	Supplement 39Manufacturing	Approved	None posted
Jun 29, 1990	Supplement 35Manufacturing	Approved	None posted
Nov 25, 1983	Supplement 30Manufacturing	Approved	None posted
Feb 28, 1972	Original application	Approved	None posted

Identifiers

Application: ANDA 80521
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