Indomethacin

ANDA 91240, held by Hetero Labs Ltd Iii. Indomethacin.

As of Nov 15, 2026, ANDA 91240 (Indomethacin), held by Hetero Labs Ltd Iii, was first approved by FDA on Apr 12, 2011, with 4 approved supplements and 0 published complete response letters.

First approved: Apr 12, 2011
Supplements approved: 4
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Indomethacin 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)
Acute gouty arthritis

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
Apr 12, 2011	Original application	Approved	None posted

Products

2 strengths and forms


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

All 5 submissions, including labeling and manufacturing supplements


Nov 21, 2024	Supplement 13Labeling · Standard review	Approved	None posted
Apr 28, 2021	Supplement 9Labeling · Standard review	Approved	None posted
Apr 26, 2021	Supplement 3Labeling · Standard review	Approved	None posted
May 9, 2016	Supplement 1Labeling · Standard review	Approved	None posted
Apr 12, 2011	Original application	Approved	None posted

Identifiers

Application: ANDA 91240
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