Indomethacin

ANDA 70488, held by Superpharm. Indomethacin.

As of Nov 15, 2026, ANDA 70488 (Indomethacin), held by Superpharm, was first approved by FDA on Oct 10, 1986, with 2 approved supplements and 0 published complete response letters.

First approved: Oct 10, 1986
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Oct 10, 1986	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Indomethacin50MG · capsule;oral	Indomethacin	Discontinued

All 3 submissions, including labeling and manufacturing supplements


Sep 18, 1989	Supplement 10Labeling	Approved	None posted
Feb 2, 1989	Supplement 9Labeling	Approved	None posted
Oct 10, 1986	Original application	Approved	None posted

Identifiers

Application: ANDA 70488
Drugs@FDA: Overview at FDA
Company: Superpharm

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