Indocin

NDA 18332, held by Cosette. Indomethacin.

As of Nov 14, 2026, NDA 18332 (Indocin), held by Cosette, was first approved by FDA on Oct 10, 1985, with 28 approved supplements and 0 published complete response letters.

First approved: Oct 10, 1985
Review: Standard
Supplements approved: 28
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDOCIN Oral Suspension 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 29 submissions below

Date	Submission	Status	Documents
Oct 10, 1985	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Indocin25MG/5ML · suspension;oral	Indomethacin	RxReference drug

All 29 submissions, including labeling and manufacturing supplements


Nov 21, 2024	Supplement 43Labeling · Standard review	Approved	Letter Label Medication Guide
Apr 28, 2021	Supplement 42Labeling · Standard review	Approved	Label Letter
Mar 26, 2019	Supplement 40Labeling · Standard review	Approved	Letter Label
May 9, 2016	Supplement 38Labeling · Standard review	Approved	Letter Label
May 9, 2016	Supplement 37Labeling · Standard review	Approved	Letter Label
Oct 16, 2014	Supplement 36Manufacturing · Standard review	Approved	None posted
May 9, 2013	Supplement 35Manufacturing · Standard review	Approved	None posted
Mar 31, 2009	Supplement 32Labeling · Standard review	Approved	Label
Jan 30, 2007	Supplement 30Labeling · Standard review	Approved	Letter Label
Jan 26, 2006	Supplement 29Labeling · Standard review	Approved	Label
Mar 24, 2005	Supplement 28Labeling · Standard review	Approved	Letter
Nov 26, 2001	Supplement 23Labeling · Standard review	Approved	None posted
Oct 31, 2001	Supplement 21Labeling · Standard review	Approved	None posted
Apr 28, 1998	Supplement 22Manufacturing · Standard review	Approved	None posted
Dec 30, 1994	Supplement 18Manufacturing · Standard review	Approved	None posted
Oct 24, 1994	Supplement 20Labeling · Standard review	Approved	None posted
Sep 26, 1994	Supplement 17Labeling · Standard review	Approved	None posted
Sep 13, 1994	Supplement 19Labeling · Standard review	Approved	None posted
May 25, 1989	Supplement 14Labeling	Approved	None posted
Jan 9, 1989	Supplement 11Labeling	Approved	None posted
Jan 6, 1989	Supplement 13Labeling	Approved	None posted
Jan 6, 1989	Supplement 9Labeling	Approved	None posted
Jun 3, 1988	Supplement 6Labeling	Approved	None posted
Mar 10, 1988	Supplement 10Manufacturing · Standard review	Approved	None posted
Sep 19, 1986	Supplement 3Labeling	Approved	None posted
Aug 15, 1986	Supplement 4Labeling	Approved	None posted
Jun 4, 1986	Supplement 2Manufacturing · Standard review	Approved	None posted
Jan 6, 1986	Supplement 1Labeling	Approved	None posted
Oct 10, 1985	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 18332
Drugs@FDA: Overview at FDA
Company: Cosette

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