Indomethacin

ANDA 215899, held by Hikma. Indomethacin.

As of Nov 15, 2026, ANDA 215899 (Indomethacin), held by Hikma, was first approved by FDA on Nov 19, 2024, with 1 approved supplement and 0 published complete response letters.

First approved: Nov 19, 2024
Review: Standard
Supplements approved: 1
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Indomethacin Suppository 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 2 submissions below

Date	Submission	Status	Documents
Nov 19, 2024	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Indomethacin50MG · suppository;rectal	Indomethacin	Rx

All 2 submissions, including labeling and manufacturing supplements


Oct 30, 2026	Supplement 1Labeling · Standard review	Approved	None posted
Nov 19, 2024	Original application	Approved	None posted

Identifiers

Application: ANDA 215899
Drugs@FDA: Overview at FDA
Company: Hikma

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