Fenoprofen Calcium

ANDA 72902, held by Sun Pharm Industries. Fenoprofen Calcium.

As of Nov 15, 2026, ANDA 72902 (Fenoprofen Calcium), held by Sun Pharm Industries, was first approved by FDA on Dec 21, 1990, with 11 approved supplements and 0 published complete response letters.

First approved: Dec 21, 1990
Supplements approved: 11
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 12 submissions below

Date	Submission	Status	Documents
Dec 21, 1990	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Fenoprofen CalciumEQ 600MG BASE · tablet;oral	Fenoprofen Calcium	Discontinued

All 12 submissions, including labeling and manufacturing supplements


Nov 21, 2024	Supplement 20Labeling · Standard review	Approved	None posted
Apr 30, 2021	Supplement 19Labeling · Standard review	Approved	None posted
May 9, 2016	Supplement 18Labeling · Standard review	Approved	None posted
Aug 16, 2007	Supplement 17Labeling	Approved	None posted
May 16, 2000	Supplement 8Manufacturing	Approved	None posted
May 16, 2000	Supplement 7Manufacturing	Approved	None posted
Dec 5, 1997	Supplement 6Manufacturing	Approved	None posted
Feb 24, 1997	Supplement 5Manufacturing	Approved	None posted
Jun 22, 1995	Supplement 4Manufacturing	Approved	None posted
Jan 12, 1994	Supplement 3Manufacturing	Approved	None posted
May 6, 1993	Supplement 2Labeling	Approved	None posted
Dec 21, 1990	Original application	Approved	None posted

Identifiers

Application: ANDA 72902
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