Isoniazid

ANDA 80936, held by Genus Lifesciences. Isoniazid.

As of Nov 15, 2026, ANDA 80936 (Isoniazid), held by Genus Lifesciences, was first approved by FDA on Aug 24, 1972, with 26 approved supplements and 0 published complete response letters.

First approved: Aug 24, 1972
Supplements approved: 26
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Isoniazid tablets, USP are recommended for all forms of tuberculosis in which organisms are susceptible. However, active tuberculosis must be treated with multiple concomitant anti-tuberculosis medications to prevent the emergence of drug resistance. Single-drug treatment of active tuberculosis with isoniazid or any other medication, is inadequate therapy. Isoniazid tablets, USP are recommended as preventive therapy for the following groups, regardless of age.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 27 submissions below

Date	Submission	Status	Documents
Aug 24, 1972	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Isoniazid100MG · tablet;oral	Isoniazid	Discontinued

All 27 submissions, including labeling and manufacturing supplements


Feb 5, 2025	Supplement 61Labeling · Standard review	Approved	None posted
Oct 24, 2024	Supplement 56Labeling · Standard review	Approved	None posted
Oct 24, 2024	Supplement 55Labeling · Standard review	Approved	None posted
Mar 16, 2000	Supplement 48Labeling	Approved	None posted
Mar 16, 2000	Supplement 47Manufacturing	Approved	None posted
Mar 16, 2000	Supplement 46Manufacturing	Approved	None posted
Mar 16, 2000	Supplement 45Manufacturing	Approved	None posted
Mar 16, 2000	Supplement 44Manufacturing	Approved	None posted
Dec 21, 1999	Supplement 49Manufacturing	Approved	None posted
May 20, 1999	Supplement 43Manufacturing	Approved	None posted
Dec 1, 1998	Supplement 42Manufacturing	Approved	None posted
Jun 15, 1998	Supplement 41Manufacturing	Approved	None posted
Sep 18, 1997	Supplement 39Manufacturing	Approved	None posted
Apr 7, 1997	Supplement 40Labeling	Approved	None posted
Dec 23, 1994	Supplement 38Manufacturing	Approved	None posted
Oct 11, 1994	Supplement 37Manufacturing	Approved	None posted
Apr 3, 1992	Supplement 36Manufacturing	Approved	None posted
Apr 3, 1992	Supplement 34Manufacturing	Approved	None posted
Jan 25, 1990	Supplement 32Labeling	Approved	None posted
Jul 11, 1989	Supplement 31Labeling	Approved	None posted
Apr 6, 1987	Supplement 29Manufacturing	Approved	None posted
Feb 21, 1986	Supplement 27Manufacturing	Approved	None posted
Feb 21, 1986	Supplement 26Manufacturing	Approved	None posted
Feb 21, 1986	Supplement 25Manufacturing	Approved	None posted
Sep 7, 1983	Supplement 22Manufacturing	Approved	None posted
Apr 26, 1983	Supplement 21Manufacturing	Approved	None posted
Aug 24, 1972	Original application	Approved	None posted

Identifiers

Application: ANDA 80936
Drugs@FDA: Overview at FDA
Company: Genus Lifesciences

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