Isoniazid

ANDA 88231, held by Duramed Pharms Barr. Isoniazid.

As of Nov 15, 2026, ANDA 88231 (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
Isoniazid100MG · tablet;oral	Isoniazid	Discontinued

All 13 submissions, including labeling and manufacturing supplements


Mar 26, 1991	Supplement 21Labeling	Approved	None posted
Aug 17, 1989	Supplement 14Labeling	Approved	None posted
May 3, 1989	Supplement 15Labeling	Approved	None posted
Dec 29, 1988	Supplement 13Manufacturing	Approved	None posted
Apr 14, 1988	Supplement 12Labeling	Approved	None posted
Jun 19, 1985	Supplement 10Manufacturing	Approved	None posted
Jun 19, 1985	Supplement 9Manufacturing	Approved	None posted
Jun 19, 1985	Supplement 7Manufacturing	Approved	None posted
May 28, 1985	Supplement 6Manufacturing	Approved	None posted
May 28, 1985	Supplement 5Manufacturing	Approved	None posted
Apr 3, 1984	Supplement 3Manufacturing	Approved	None posted
Aug 5, 1983	Supplement 1Manufacturing	Approved	None posted
Mar 17, 1983	Original application	Approved	None posted

Identifiers

Application: ANDA 88231
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