Indomethacin

ANDA 91401, held by Sun Pharm Inds Inc. Indomethacin.

As of Nov 15, 2026, ANDA 91401 (Indomethacin), held by Sun Pharm Inds Inc, was first approved by FDA on Mar 28, 2013, with 4 approved supplements and 0 published complete response letters.

First approved: Mar 28, 2013
Supplements approved: 4
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
Mar 28, 2013	Original application	Approved	None posted

Products

2 strengths and forms


Indomethacin25MG · capsule;oral	Indomethacin	Discontinued
Indomethacin50MG · capsule;oral	Indomethacin	Discontinued

All 5 submissions, including labeling and manufacturing supplements


Nov 21, 2024	Supplement 6Labeling · Standard review	Approved	None posted
Apr 29, 2021	Supplement 4Labeling · Standard review	Approved	None posted
Apr 29, 2021	Supplement 5Labeling · Standard review	Approved	None posted
May 9, 2016	Supplement 3Labeling · Standard review	Approved	None posted
Mar 28, 2013	Original application	Approved	None posted

Identifiers

Application: ANDA 91401
Drugs@FDA: Overview at FDA
Company: Sun Pharmaceutical Industries

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