Indomethacin

NDA 18829, held by Chartwell Molecules. Indomethacin.

As of Nov 13, 2026, NDA 18829 (Indomethacin), held by Chartwell Molecules, was first approved by FDA on Aug 6, 1984, with 17 approved supplements and 0 published complete response letters.

First approved: Aug 6, 1984
Supplements approved: 17
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Carefully consider the potential benefits and risks of indomethacin capsules, USP and other treatment options before deciding to use indomethacin. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals ( see Warnings: Gastrointestinal Bleeding, Ulceration, and Perforation ). Indomethacin has been found effective in active stages of the following: 1. Moderate to severe rheumatoid arthritis including acute flares of chronic disease. 2. Moderate to severe ankylosing spondylitis. 3. Moderate to severe osteoarthritis. 4. Acute painful shoulder (bursitis and/or tendinitis). 5. 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
Aug 6, 1984	Original application	Approved	None posted

Products

2 strengths and forms


Indomethacin50MG · capsule;oral	Indomethacin	Rx
Indomethacin25MG · capsule;oral	Indomethacin	Rx

All 18 submissions, including labeling and manufacturing supplements


Nov 21, 2024	Supplement 25Labeling · Standard review	Approved	Label Medication Guide Letter
Apr 28, 2021	Supplement 23Labeling · Standard review	Approved	Label Letter
May 9, 2016	Supplement 22Labeling · Standard review	Approved	Letter Label
Jul 26, 1996	Supplement 21Labeling	Approved	None posted
Jun 7, 1996	Supplement 20Manufacturing	Approved	None posted
May 27, 1992	Supplement 19Labeling	Approved	None posted
Apr 29, 1991	Supplement 18Labeling	Approved	None posted
Jun 8, 1989	Supplement 17Labeling	Approved	None posted
May 2, 1989	Supplement 14Manufacturing	Approved	None posted
Mar 21, 1989	Supplement 16Labeling	Approved	None posted
Nov 9, 1988	Supplement 15Labeling	Approved	None posted
Oct 28, 1987	Supplement 12Manufacturing	Approved	None posted
Apr 14, 1986	Supplement 9Manufacturing	Approved	None posted
Apr 14, 1986	Supplement 7Manufacturing	Approved	None posted
Jun 19, 1985	Supplement 5Manufacturing	Approved	None posted
Jun 19, 1985	Supplement 2Manufacturing	Approved	None posted
Jun 19, 1985	Supplement 1Manufacturing	Approved	None posted
Aug 6, 1984	Original application	Approved	None posted

Identifiers

Application: NDA 18829
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