Isoniazid

ANDA 80153, held by Impax Labs. Isoniazid.

As of Nov 15, 2026, ANDA 80153 (Isoniazid), held by Impax Labs, was first approved by FDA on Aug 1, 1973, with 1 approved supplement and 0 published complete response letters.

First approved: Aug 1, 1973
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Aug 1, 1973	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Isoniazid100MG · tablet;oral	Isoniazid	Discontinued

All 2 submissions, including labeling and manufacturing supplements


Jun 18, 1992	Supplement 13Labeling	Approved	None posted
Aug 1, 1973	Original application	Approved	None posted

Identifiers

Application: ANDA 80153
Drugs@FDA: Overview at FDA
Company: Impax 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