Fenoprofen Calcium

ANDA 72602, held by Watson Labs. Fenoprofen Calcium.

As of Nov 15, 2026, ANDA 72602 (Fenoprofen Calcium), held by Watson Labs, was first approved by FDA on Oct 11, 1988, with 7 approved supplements and 0 published complete response letters.

First approved: Oct 11, 1988
Supplements approved: 7
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below

Date	Submission	Status	Documents
Oct 11, 1988	Original application	Approved	None posted

Products

1 strengths and forms

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

All 8 submissions, including labeling and manufacturing supplements


May 9, 2016	Supplement 7Labeling · Standard review	Approved	None posted
Feb 29, 2016	Supplement 8Labeling · Standard review	Approved	None posted
Aug 2, 1991	Supplement 5Labeling	Approved	None posted
May 31, 1991	Supplement 3Manufacturing	Approved	None posted
Nov 19, 1990	Supplement 4Manufacturing	Approved	None posted
Jun 29, 1990	Supplement 2Manufacturing	Approved	None posted
Mar 31, 1989	Supplement 1Labeling	Approved	None posted
Oct 11, 1988	Original application	Approved	None posted

Identifiers

Application: ANDA 72602
Drugs@FDA: Overview at FDA
Company: Watson 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