Isoniazid

ANDA 83633, held by Sun Pharm Industries. Isoniazid.

As of Nov 15, 2026, ANDA 83633 (Isoniazid), held by Sun Pharm Industries, was first approved by FDA on May 11, 1976, with 14 approved supplements and 0 published complete response letters.

First approved: May 11, 1976
Supplements approved: 14
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 15 submissions below

Date	Submission	Status	Documents
May 11, 1976	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Isoniazid300MG · tablet;oral	Isoniazid	Discontinued

All 15 submissions, including labeling and manufacturing supplements


Jul 24, 2002	Supplement 21Manufacturing	Approved	None posted
Feb 8, 2002	Supplement 20Manufacturing	Approved	None posted
Nov 2, 2001	Supplement 18Manufacturing	Approved	None posted
Sep 24, 2001	Supplement 19Manufacturing	Approved	None posted
Dec 18, 2000	Supplement 14Manufacturing	Approved	None posted
Dec 18, 2000	Supplement 15Manufacturing	Approved	None posted
Dec 18, 2000	Supplement 16Manufacturing	Approved	None posted
Dec 18, 2000	Supplement 17Manufacturing	Approved	None posted
Mar 17, 1998	Supplement 13Labeling	Approved	None posted
Mar 11, 1997	Supplement 12Manufacturing	Approved	None posted
Mar 10, 1994	Supplement 10Labeling	Approved	None posted
Jul 31, 1992	Supplement 11Manufacturing	Approved	None posted
Dec 9, 1988	Supplement 9Labeling	Approved	None posted
Jul 19, 1982	Supplement 8Manufacturing	Approved	None posted
May 11, 1976	Original application	Approved	None posted

Identifiers

Application: ANDA 83633
Drugs@FDA: Overview at FDA
Company: Sun Pharmaceutical Industries

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