Indomethacin

ANDA 201807, held by Hetero Labs Ltd Iii. Indomethacin.

As of Nov 15, 2026, ANDA 201807 (Indomethacin), held by Hetero Labs Ltd Iii, was first approved by FDA on Sep 28, 2012, with 3 approved supplements and 0 published complete response letters.

First approved: Sep 28, 2012
Supplements approved: 3
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Indomethacin extended-release capsules are 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)

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Sep 28, 2012	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Indomethacin75MG · capsule, extended release;oral	Indomethacin	Rx

All 4 submissions, including labeling and manufacturing supplements


Nov 21, 2024	Supplement 8Labeling · Standard review	Approved	None posted
Apr 28, 2021	Supplement 5Labeling · Standard review	Approved	None posted
May 9, 2016	Supplement 1Labeling · Standard review	Approved	None posted
Sep 28, 2012	Original application	Approved	None posted

Identifiers

Application: ANDA 201807
Drugs@FDA: Overview at FDA
Company: Hetero Labs Ltd Iii

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