Indomethacin

ANDA 70651, held by Chartwell Molecules. Indomethacin.

As of Nov 15, 2026, ANDA 70651 (Indomethacin), held by Chartwell Molecules, was first approved by FDA on Mar 5, 1986, with 17 approved supplements and 0 published complete response letters.

First approved: Mar 5, 1986
Supplements approved: 17
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Indomethacin Capsules is indicated for: Moderate to severe rheumatoid arthritis including acute flares of chronic disease Moderate to severe ankylosing spondylitis Moderate to severe osteoarthritis Acute painful shoulder (bursitis and/or tendinitis) Acute gouty arthritis

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 18 submissions below

Date	Submission	Status	Documents
Mar 5, 1986	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Indomethacin50MG · capsule;oral	Indomethacin	Rx

All 18 submissions, including labeling and manufacturing supplements


Nov 21, 2024	Supplement 19Labeling · Standard review	Approved	None posted
Nov 19, 2024	Supplement 18Labeling · Standard review	Approved	None posted
Apr 28, 2021	Supplement 16Labeling · Standard review	Approved	None posted
Apr 26, 2021	Supplement 15Labeling · Standard review	Approved	None posted
May 9, 2016	Supplement 14Labeling · Standard review	Approved	None posted
Jul 26, 1996	Supplement 13Labeling	Approved	None posted
Jun 7, 1996	Supplement 12Manufacturing	Approved	None posted
Sep 10, 1991	Supplement 11Labeling	Approved	None posted
Jul 16, 1991	Supplement 10Labeling	Approved	None posted
May 2, 1989	Supplement 9Labeling	Approved	None posted
May 2, 1989	Supplement 6Manufacturing	Approved	None posted
Feb 2, 1989	Supplement 8Labeling	Approved	None posted
Oct 26, 1988	Supplement 7Labeling	Approved	None posted
Mar 24, 1987	Supplement 2Labeling	Approved	None posted
Oct 27, 1986	Supplement 4Manufacturing	Approved	None posted
Sep 15, 1986	Supplement 3Labeling	Approved	None posted
Mar 21, 1986	Supplement 1Labeling	Approved	None posted
Mar 5, 1986	Original application	Approved	None posted

Identifiers

Application: ANDA 70651
Drugs@FDA: Overview at FDA
Company: Chartwell Molecules

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