Isoniazid

ANDA 88119, held by Duramed Pharms Barr. Isoniazid.

As of Nov 15, 2026, ANDA 88119 (Isoniazid), held by Duramed Pharms Barr, was first approved by FDA on Mar 17, 1983, with 12 approved supplements and 0 published complete response letters.

First approved: Mar 17, 1983
Supplements approved: 12
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 13 submissions below

Date	Submission	Status	Documents
Mar 17, 1983	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Isoniazid300MG · tablet;oral	Isoniazid	Discontinued

All 13 submissions, including labeling and manufacturing supplements


May 12, 1997	Supplement 15Labeling	Approved	None posted
Nov 9, 1990	Supplement 14Labeling	Approved	None posted
Nov 15, 1989	Supplement 13Labeling	Approved	None posted
Aug 17, 1989	Supplement 11Labeling	Approved	None posted
Mar 21, 1989	Supplement 12Labeling	Approved	None posted
Mar 31, 1988	Supplement 10Labeling	Approved	None posted
Jun 19, 1985	Supplement 5Manufacturing	Approved	None posted
Jun 19, 1985	Supplement 6Manufacturing	Approved	None posted
Jun 19, 1985	Supplement 8Manufacturing	Approved	None posted
May 29, 1985	Supplement 3Manufacturing	Approved	None posted
May 29, 1985	Supplement 4Manufacturing	Approved	None posted
Aug 5, 1983	Supplement 1Manufacturing	Approved	None posted
Mar 17, 1983	Original application	Approved	None posted

Identifiers

Application: ANDA 88119
Drugs@FDA: Overview at FDA
Company: Duramed Pharmaceuticals (Barr)

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