Indomethacin

ANDA 202711, held by Zydus Pharms. Indomethacin.

As of Nov 15, 2026, ANDA 202711 (Indomethacin), held by Zydus Pharms, was first approved by FDA on Sep 25, 2017, with 3 approved supplements and 0 published complete response letters.

First approved: Sep 25, 2017
Supplements approved: 3
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Sep 25, 2017	Original application	Approved	Letter

Products

1 strengths and forms

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

All 4 submissions, including labeling and manufacturing supplements


Nov 21, 2024	Supplement 3Labeling · Standard review	Approved	None posted
Apr 28, 2021	Supplement 2Labeling · Standard review	Approved	None posted
Sep 18, 2019	Supplement 1Labeling · Standard review	Approved	None posted
Sep 25, 2017	Original application	Approved	Letter

Identifiers

Application: ANDA 202711
Drugs@FDA: Overview at FDA
Company: Zydus Pharmaceuticals (USA)

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