Indomethacin

ANDA 79175, held by Avanthi Inc. Indomethacin.

As of Nov 15, 2026, ANDA 79175 (Indomethacin), held by Avanthi Inc, was first approved by FDA on Mar 6, 2009, with 3 approved supplements and 0 published complete response letters.

First approved: Mar 6, 2009
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
Mar 6, 2009	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 21Labeling · Standard review	Approved	None posted
May 12, 2021	Supplement 13Labeling · Standard review	Approved	None posted
May 9, 2016	Supplement 7Labeling · Standard review	Approved	None posted
Mar 6, 2009	Original application	Approved	None posted

Identifiers

Application: ANDA 79175
Drugs@FDA: Overview at FDA
Company: Avanthi Inc

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