Indomethacin

ANDA 70674, held by Sandoz. Indomethacin.

As of Nov 15, 2026, ANDA 70674 (Indomethacin), held by Sandoz, was first approved by FDA on Apr 29, 1987, with 14 approved supplements and 0 published complete response letters.

First approved: Apr 29, 1987
Supplements approved: 14
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 15 submissions below

Date	Submission	Status	Documents
Apr 29, 1987	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Indomethacin50MG · capsule;oral	Indomethacin	Rx

All 15 submissions, including labeling and manufacturing supplements


Nov 21, 2024	Supplement 24Labeling · Standard review	Approved	None posted
Apr 11, 2024	Supplement 23Labeling · Standard review	Approved	None posted
Apr 28, 2021	Supplement 22Labeling · Standard review	Approved	None posted
Nov 12, 2019	Supplement 20Labeling · Standard review	Approved	None posted
Nov 12, 2019	Supplement 21Labeling · Standard review	Approved	None posted
Apr 15, 2007	Supplement 10Labeling	Approved	None posted
Jul 1, 1996	Supplement 8Labeling	Approved	None posted
Apr 29, 1996	Supplement 7Labeling	Approved	None posted
May 23, 1995	Supplement 5Manufacturing	Approved	None posted
Feb 1, 1995	Supplement 6Manufacturing	Approved	None posted
Sep 10, 1990	Supplement 4Labeling	Approved	None posted
Oct 24, 1989	Supplement 3Labeling	Approved	None posted
Feb 2, 1989	Supplement 2Labeling	Approved	None posted
Mar 3, 1988	Supplement 1Manufacturing	Approved	None posted
Apr 29, 1987	Original application	Approved	None posted

Identifiers

Application: ANDA 70674
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