Isoniazid

ANDA 80522, held by Watson Labs. Isoniazid.

As of Nov 15, 2026, ANDA 80522 (Isoniazid), held by Watson Labs, was first approved by FDA on Feb 28, 1972, with 2 approved supplements and 0 published complete response letters.

First approved: Feb 28, 1972
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

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

Products

1 strengths and forms

Product	Active ingredient	Marketing
Isoniazid50MG · tablet;oral	Isoniazid	Discontinued

All 3 submissions, including labeling and manufacturing supplements


Aug 18, 1997	Supplement 13Labeling	Approved	None posted
Dec 1, 1992	Supplement 12Labeling	Approved	None posted
Feb 28, 1972	Original application	Approved	None posted

Identifiers

Application: ANDA 80522
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