Isoniazid

ANDA 80136, held by Sun Pharm Industries. Isoniazid.

As of Nov 15, 2026, ANDA 80136 (Isoniazid), held by Sun Pharm Industries, was first approved by FDA on Nov 13, 1970, with 13 approved supplements and 0 published complete response letters.

First approved: Nov 13, 1970
Supplements approved: 13
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 14 submissions below

Date	Submission	Status	Documents
Nov 13, 1970	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Isoniazid100MG · tablet;oral	Isoniazid	Discontinued

All 14 submissions, including labeling and manufacturing supplements


Jul 24, 2002	Supplement 36Manufacturing	Approved	None posted
Feb 8, 2002	Supplement 35Manufacturing	Approved	None posted
Nov 2, 2001	Supplement 33Manufacturing	Approved	None posted
Sep 24, 2001	Supplement 34Manufacturing	Approved	None posted
Dec 18, 2000	Supplement 29Manufacturing	Approved	None posted
Dec 18, 2000	Supplement 30Manufacturing	Approved	None posted
Dec 18, 2000	Supplement 31Manufacturing	Approved	None posted
Dec 18, 2000	Supplement 32Manufacturing	Approved	None posted
Mar 17, 1998	Supplement 28Labeling	Approved	None posted
Mar 11, 1997	Supplement 27Manufacturing	Approved	None posted
Mar 10, 1994	Supplement 25Labeling	Approved	None posted
Jul 31, 1992	Supplement 26Manufacturing	Approved	None posted
Dec 9, 1988	Supplement 24Labeling	Approved	None posted
Nov 13, 1970	Original application	Approved	None posted

Identifiers

Application: ANDA 80136
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