Fenoprofen Calcium

ANDA 72407, held by Watson Labs Teva. Fenoprofen Calcium.

As of Nov 15, 2026, ANDA 72407 (Fenoprofen Calcium), held by Watson Labs Teva, was first approved by FDA on Jun 13, 1988, with 10 approved supplements and 0 published complete response letters.

First approved: Jun 13, 1988
Supplements approved: 10
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 11 submissions below

Date	Submission	Status	Documents
Jun 13, 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 11 submissions, including labeling and manufacturing supplements


May 11, 2016	Supplement 11Labeling · Standard review	Approved	None posted
May 9, 2016	Supplement 10Labeling · Standard review	Approved	None posted
Jan 31, 1997	Supplement 9Manufacturing	Approved	None posted
May 7, 1991	Supplement 8Labeling	Approved	None posted
Jul 12, 1989	Supplement 3Manufacturing	Approved	None posted
Jul 11, 1989	Supplement 2Manufacturing	Approved	None posted
Jul 11, 1989	Supplement 4Manufacturing	Approved	None posted
May 24, 1989	Supplement 6Bioequivalence	Approved	None posted
Apr 21, 1989	Supplement 5Labeling	Approved	None posted
Mar 31, 1989	Supplement 1Labeling	Approved	None posted
Jun 13, 1988	Original application	Approved	None posted

Identifiers

Application: ANDA 72407
Drugs@FDA: Overview at FDA
Company: Watson Labs Teva

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