Indomethacin

ANDA 70719, held by Heritage Pharma. Indomethacin.

As of Nov 15, 2026, ANDA 70719 (Indomethacin), held by Heritage Pharma, was first approved by FDA on Feb 12, 1986, with 21 approved supplements and 0 published complete response letters.

First approved: Feb 12, 1986
Supplements approved: 21
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 22 submissions below

Date	Submission	Status	Documents
Feb 12, 1986	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Indomethacin25MG · capsule;oral	Indomethacin	Discontinued

All 22 submissions, including labeling and manufacturing supplements


Nov 21, 2024	Supplement 31Labeling · Standard review	Approved	None posted
Apr 28, 2021	Supplement 30Labeling · Standard review	Approved	None posted
Apr 23, 2021	Supplement 29Labeling · Standard review	Approved	None posted
May 9, 2016	Supplement 28Labeling · Standard review	Approved	None posted
Jan 28, 2008	Supplement 25Labeling	Approved	None posted
Nov 16, 2006	Supplement 20Labeling	Approved	None posted
Jul 29, 2002	Supplement 15Manufacturing	Approved	None posted
Sep 12, 2001	Supplement 14Manufacturing	Approved	None posted
Apr 28, 2000	Supplement 13Labeling	Approved	None posted
Apr 28, 2000	Supplement 12Manufacturing	Approved	None posted
Jan 28, 2000	Supplement 11Manufacturing	Approved	None posted
Nov 5, 1998	Supplement 10Manufacturing	Approved	None posted
May 30, 1997	Supplement 9Manufacturing	Approved	None posted
Dec 1, 1995	Supplement 8Manufacturing	Approved	None posted
Dec 1, 1995	Supplement 7Manufacturing	Approved	None posted
Nov 1, 1994	Supplement 6Manufacturing	Approved	None posted
Apr 29, 1993	Supplement 5Manufacturing	Approved	None posted
Apr 29, 1993	Supplement 4Labeling	Approved	None posted
Dec 18, 1991	Supplement 3Labeling	Approved	None posted
Aug 30, 1989	Supplement 2Labeling	Approved	None posted
May 13, 1987	Supplement 1Labeling	Approved	None posted
Feb 12, 1986	Original application	Approved	None posted

Identifiers

Application: ANDA 70719
Drugs@FDA: Overview at FDA
Company: Heritage 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