Indocin

NDA 18878, held by Recordati Rare. Indomethacin Sodium.

As of Nov 13, 2026, NDA 18878 (Indocin), held by Recordati Rare, was first approved by FDA on Jan 30, 1985, with 17 approved supplements and 0 published complete response letters.

First approved: Jan 30, 1985
Review: Priority
Supplements approved: 17
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 18 submissions below

Date	Submission	Status	Documents
Jan 30, 1985	Original applicationNew dosage form · Priority review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
IndocinEQ 1MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · injectable;injection	Indomethacin Sodium	DiscontinuedReference drug

All 18 submissions, including labeling and manufacturing supplements


Mar 26, 2021	Supplement 29Labeling · Standard review	Approved	Letter Label
Jan 19, 2010	Supplement 27Labeling	Approved	Letter Label
Jan 12, 2007	Supplement 24Labeling · Standard review	Approved	Letter Label
Feb 1, 2006	Supplement 23Labeling · Standard review	Approved	Letter Label
May 6, 2003	Supplement 19Labeling · Standard review	Approved	Letter
May 6, 2003	Supplement 18Labeling · Standard review	Approved	Letter
Nov 8, 2002	Supplement 20Manufacturing · Priority review	Approved	None posted
Feb 12, 2001	Supplement 17Manufacturing · Priority review	Approved	None posted
Nov 16, 2000	Supplement 16Manufacturing · Priority review	Approved	None posted
Oct 24, 2000	Supplement 15Manufacturing · Priority review	Approved	None posted
May 15, 1998	Supplement 14Labeling · Standard review	Approved	None posted
Oct 14, 1997	Supplement 13Manufacturing · Priority review	Approved	None posted
Sep 21, 1994	Supplement 10Labeling	Approved	None posted
Sep 13, 1994	Supplement 11Labeling · Standard review	Approved	None posted
Jun 8, 1988	Supplement 5Labeling	Approved	None posted
Oct 31, 1986	Supplement 1Manufacturing · Priority review	Approved	None posted
Jun 20, 1985	Supplement 2Labeling	Approved	None posted
Jan 30, 1985	Original applicationNew dosage form · Priority review	Approved	None posted

Identifiers

Application: NDA 18878
Drugs@FDA: Overview at FDA
Company: Recordati Rare Diseases

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