Indomethacin

As of Nov 15, 2026, ANDA 76114 (Indomethacin), held by Able, was first approved by FDA on Feb 6, 2002, with 5 approved supplements and 0 published complete response letters.

First approved: Feb 6, 2002
Supplements approved: 5
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
Feb 6, 2002	Original application	Approved	Letter

Products

1 strengths and forms

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

All 6 submissions, including labeling and manufacturing supplements


Nov 8, 2002	Supplement 5Manufacturing	Approved	None posted
Nov 8, 2002	Supplement 4Labeling	Approved	None posted
Nov 8, 2002	Supplement 3Manufacturing	Approved	None posted
Nov 8, 2002	Supplement 2Manufacturing	Approved	None posted
Aug 19, 2002	Supplement 1Manufacturing	Approved	None posted
Feb 6, 2002	Original application	Approved	Letter

Identifiers

Application: ANDA 76114
Drugs@FDA: Overview at FDA
Company: Able Laboratories

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