Indomethacin

ANDA 74464, held by Sandoz. Indomethacin.

As of Nov 15, 2026, ANDA 74464 (Indomethacin), held by Sandoz, was first approved by FDA on May 28, 1998, with 10 approved supplements and 0 published complete response letters.

First approved: May 28, 1998
Supplements approved: 10
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 11 submissions below

Date	Submission	Status	Documents
May 28, 1998	Original application	Approved	Letter Review

Products

1 strengths and forms

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

All 11 submissions, including labeling and manufacturing supplements


Nov 21, 2024	Supplement 25Labeling · Standard review	Approved	None posted
Oct 16, 2023	Supplement 23Labeling · Standard review	Approved	None posted
Apr 28, 2021	Supplement 21Labeling · Standard review	Approved	None posted
Feb 2, 2020	Supplement 19Labeling · Standard review	Approved	None posted
Feb 2, 2020	Supplement 20Labeling · Standard review	Approved	None posted
May 9, 2016	Supplement 17Labeling · Standard review	Approved	None posted
Mar 13, 2006	Supplement 4Labeling	Approved	None posted
Mar 13, 2006	Supplement 5Labeling	Approved	None posted
Feb 2, 2000	Supplement 2Manufacturing	Approved	None posted
Feb 12, 1999	Supplement 1Manufacturing	Approved	None posted
May 28, 1998	Original application	Approved	Letter Review

Identifiers

Application: ANDA 74464
Drugs@FDA: Overview at FDA
Company: Sandoz

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