Fenoprofen Calcium

Relieves mild to moderate pain. ANDA 214475, held by Rising. Fenoprofen Calcium.

As of Nov 15, 2026, ANDA 214475 (Fenoprofen Calcium), held by Rising, was first approved by FDA on Jul 18, 2022, with 2 approved supplements and 0 published complete response letters.

First approved: Jul 18, 2022
Review: Standard
Supplements approved: 2
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Fenoprofen calcium is indicated for:

Relief of mild to moderate pain in adults
Relief of the signs and symptoms of rheumatoid arthritis
Relief of the signs and symptoms of osteoarthritis

Full prescribing information on DailyMed ↗

Approvals and New Uses

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

Date	Submission	Status	Documents
Jul 18, 2022	Original application	Approved	Letter

Products

3 strengths and forms


Fenoprofen CalciumEQ 400MG BASE · capsule;oral	Fenoprofen Calcium	Rx
Fenoprofen CalciumEQ 200MG BASE · capsule;oral	Fenoprofen Calcium	Rx
Fenoprofen CalciumEQ 300MG BASE · capsule;oral	Fenoprofen Calcium	Rx

All 3 submissions, including labeling and manufacturing supplements


Nov 21, 2024	Supplement 2Labeling · Standard review	Approved	None posted
Jul 26, 2024	Supplement 1Manufacturing	Approved	None posted
Jul 18, 2022	Original application	Approved	Letter

Identifiers

Application: ANDA 214475
Drugs@FDA: Overview at FDA
Company: Rising Pharmaceuticals

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