Isoniazid

ANDA 87425, held by Hikma Intl Pharms. Isoniazid.

As of Nov 15, 2026, ANDA 87425 (Isoniazid), held by Hikma Intl Pharms, was first approved by FDA on Jul 14, 1981, with 19 approved supplements and 0 published complete response letters.

First approved: Jul 14, 1981
Supplements approved: 19
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 20 submissions below

Date	Submission	Status	Documents
Jul 14, 1981	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Isoniazid300MG · tablet;oral	Isoniazid	Discontinued

All 20 submissions, including labeling and manufacturing supplements


Feb 5, 2025	Supplement 38Labeling · Standard review	Approved	None posted
Jan 31, 2025	Supplement 36Labeling · Standard review	Approved	None posted
Jan 31, 2025	Supplement 34Labeling · Standard review	Approved	None posted
Oct 21, 2008	Supplement 31Labeling	Approved	None posted
Oct 1, 1998	Supplement 26Manufacturing	Approved	None posted
Sep 8, 1997	Supplement 23Manufacturing	Approved	None posted
Sep 8, 1997	Supplement 22Manufacturing	Approved	None posted
Aug 12, 1997	Supplement 25Manufacturing	Approved	None posted
Aug 12, 1997	Supplement 24Manufacturing	Approved	None posted
Aug 12, 1997	Supplement 20Labeling	Approved	None posted
Aug 12, 1997	Supplement 19Manufacturing	Approved	None posted
Feb 18, 1997	Supplement 21Labeling	Approved	None posted
Oct 23, 1995	Supplement 18Manufacturing	Approved	None posted
Oct 23, 1995	Supplement 17Manufacturing	Approved	None posted
Oct 23, 1995	Supplement 16Manufacturing	Approved	None posted
Oct 23, 1995	Supplement 15Labeling	Approved	None posted
Oct 23, 1995	Supplement 14Manufacturing	Approved	None posted
Oct 23, 1995	Supplement 13Manufacturing	Approved	None posted
Oct 23, 1995	Supplement 12Manufacturing	Approved	None posted
Jul 14, 1981	Original application	Approved	None posted

Identifiers

Application: ANDA 87425
Drugs@FDA: Overview at FDA
Company: Hikma International Pharmaceuticals

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