Laniazid

ANDA 89776, held by Chartwell Molecular. Isoniazid.

As of Nov 15, 2026, ANDA 89776 (Laniazid), held by Chartwell Molecular, was first approved by FDA on Jun 13, 1988, with 15 approved supplements and 0 published complete response letters.

First approved: Jun 13, 1988
Supplements approved: 15
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Isoniazid Tablets 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 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 16 submissions below

Date	Submission	Status	Documents
Jun 13, 1988	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Laniazid300MG · tablet;oral	Isoniazid	Discontinued

All 16 submissions, including labeling and manufacturing supplements


Feb 5, 2025	Supplement 29Labeling · Standard review	Approved	None posted
Jan 30, 2025	Supplement 23Labeling · Standard review	Approved	None posted
Nov 21, 2001	Supplement 19Manufacturing	Approved	None posted
Nov 21, 2001	Supplement 18Labeling	Approved	None posted
Nov 21, 2001	Supplement 17Manufacturing	Approved	None posted
Nov 21, 2001	Supplement 16Manufacturing	Approved	None posted
Jul 23, 2001	Supplement 15Manufacturing	Approved	None posted
May 14, 1997	Supplement 14Labeling	Approved	None posted
Dec 11, 1996	Supplement 13Manufacturing	Approved	None posted
Dec 11, 1996	Supplement 12Labeling	Approved	None posted
Dec 11, 1996	Supplement 11Manufacturing	Approved	None posted
Dec 11, 1996	Supplement 10Manufacturing	Approved	None posted
Dec 11, 1996	Supplement 9Manufacturing	Approved	None posted
Dec 11, 1996	Supplement 8Manufacturing	Approved	None posted
Jan 9, 1990	Supplement 1Labeling	Approved	None posted
Jun 13, 1988	Original application	Approved	None posted

Identifiers

Application: ANDA 89776
Drugs@FDA: Overview at FDA
Company: Chartwell Molecular

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