Indomethacin

ANDA 70624, held by Rising. Indomethacin.

As of Nov 15, 2026, ANDA 70624 (Indomethacin), held by Rising, was first approved by FDA on Sep 4, 1985, with 25 approved supplements and 0 published complete response letters.

First approved: Sep 4, 1985
Supplements approved: 25
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 26 submissions below

Date	Submission	Status	Documents
Sep 4, 1985	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Indomethacin50MG · capsule;oral	Indomethacin	Discontinued

All 26 submissions, including labeling and manufacturing supplements


Nov 21, 2024	Supplement 41Labeling · Standard review	Approved	None posted
Apr 28, 2021	Supplement 39Labeling · Standard review	Approved	None posted
Apr 2, 2021	Supplement 38Labeling · Standard review	Approved	None posted
Apr 2, 2021	Supplement 35Labeling · Standard review	Approved	None posted
May 9, 2016	Supplement 33Labeling · Standard review	Approved	None posted
Apr 28, 2008	Supplement 29Labeling	Approved	None posted
Jun 27, 2006	Supplement 24Labeling	Approved	None posted
Sep 26, 2002	Supplement 20Manufacturing	Approved	None posted
Aug 22, 2002	Supplement 19Labeling	Approved	None posted
Feb 25, 1998	Supplement 18Manufacturing	Approved	None posted
Feb 5, 1998	Supplement 17Manufacturing	Approved	None posted
Apr 16, 1996	Supplement 16Labeling	Approved	None posted
May 2, 1994	Supplement 14Manufacturing	Approved	None posted
Oct 5, 1993	Supplement 15Labeling	Approved	None posted
Apr 20, 1993	Supplement 12Labeling	Approved	None posted
Dec 10, 1992	Supplement 11Labeling	Approved	None posted
Jan 31, 1990	Supplement 10Manufacturing	Approved	None posted
Nov 20, 1989	Supplement 9Labeling	Approved	None posted
Jun 30, 1989	Supplement 8Labeling	Approved	None posted
Feb 16, 1989	Supplement 7Labeling	Approved	None posted
Apr 14, 1988	Supplement 6Labeling	Approved	None posted
Sep 24, 1987	Supplement 5Manufacturing	Approved	None posted
Aug 14, 1986	Supplement 3Manufacturing	Approved	None posted
Jun 20, 1986	Supplement 4Labeling	Approved	None posted
Apr 8, 1986	Supplement 2Labeling	Approved	None posted
Sep 4, 1985	Original application	Approved	None posted

Identifiers

Application: ANDA 70624
Drugs@FDA: Overview at FDA
Company: Rising Pharmaceuticals

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