FDA — authorised 20 April 1988
- Application: ANDA072326
- Marketing authorisation holder: DAVA PHARMS INC
- Local brand name: FENOPROFEN CALCIUM
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 FENOPROFEN CALCIUM in United States
FDA authorised FENOPROFEN CALCIUM on 20 April 1988 · 37 US adverse-event reports
Marketing authorisations
FDA — authorised 2 May 1988
- Application: ANDA072274
- Marketing authorisation holder: ANI PHARMS
- Local brand name: FENOPROFEN CALCIUM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 8 June 1988
- Application: ANDA072267
- Marketing authorisation holder: PHARMACO
- Local brand name: FENOPROFEN CALCIUM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 August 1988
- Application: ANDA071738
- Marketing authorisation holder: QUANTUM PHARMICS
- Local brand name: FENOPROFEN CALCIUM
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 29 August 1988
- Application: ANDA072557
- Marketing authorisation holder: IVAX SUB TEVA PHARMS
- Local brand name: FENOPROFEN CALCIUM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 11 October 1988
- Application: ANDA072602
- Marketing authorisation holder: WATSON LABS
- Local brand name: FENOPROFEN CALCIUM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 14 October 1988
- Application: ANDA072395
- Marketing authorisation holder: RISING
- Local brand name: FENOPROFEN CALCIUM
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 17 October 1988
- Application: ANDA072396
- Marketing authorisation holder: RISING
- Local brand name: FENOPROFEN CALCIUM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 17 October 1988
- Application: ANDA072394
- Marketing authorisation holder: RISING
- Local brand name: FENOPROFEN CALCIUM
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 21 December 1990
- Application: ANDA072902
- Marketing authorisation holder: SUN PHARM INDUSTRIES
- Local brand name: FENOPROFEN CALCIUM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 19 August 1991
- Application: ANDA072982
- Marketing authorisation holder: WATSON LABS
- Local brand name: FENOPROFEN CALCIUM
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 19 August 1991
- Application: ANDA072981
- Marketing authorisation holder: WATSON LABS
- Local brand name: FENOPROFEN CALCIUM
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 2 April 1998
- Application: NDA017604
- Marketing authorisation holder: PHARMACO
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 18 July 2022
- Application: ANDA214475
- Marketing authorisation holder: RISING
- Local brand name: FENOPROFEN CALCIUM
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 16 May 2023
- Application: ANDA215548
- Marketing authorisation holder: MISEMER
- Local brand name: FENOPROFEN CALCIUM
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA072293
- Marketing authorisation holder: WATSON LABS
- Local brand name: FENOPROFEN CALCIUM
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA072294
- Marketing authorisation holder: WATSON LABS
- Local brand name: FENOPROFEN CALCIUM
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA072307
- Marketing authorisation holder: AM THERAP
- Local brand name: FENOPROFEN CALCIUM
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA072308
- Marketing authorisation holder: AM THERAP
- Local brand name: FENOPROFEN CALCIUM
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA072309
- Marketing authorisation holder: AM THERAP
- Local brand name: FENOPROFEN CALCIUM
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA072356
- Marketing authorisation holder: HALSEY
- Local brand name: FENOPROFEN CALCIUM
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA072165
- Marketing authorisation holder: WATSON LABS
- Local brand name: FENOPROFEN CALCIUM
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA072194
- Marketing authorisation holder: QUANTUM PHARMICS
- Local brand name: FENOPROFEN CALCIUM
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA072214
- Marketing authorisation holder: QUANTUM PHARMICS
- Local brand name: FENOPROFEN CALCIUM
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA072357
- Marketing authorisation holder: HALSEY
- Local brand name: FENOPROFEN CALCIUM
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA072362
- Marketing authorisation holder: USL PHARMA
- Local brand name: FENOPROFEN CALCIUM
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA072355
- Marketing authorisation holder: HALSEY
- Local brand name: FENOPROFEN CALCIUM
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA072946
- Marketing authorisation holder: WARNER CHILCOTT
- Local brand name: FENOPROFEN CALCIUM
- Indication: CAPSULE — ORAL
- Status: approved
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 20 April 2025 – 20 April 2026
- Total reports: 37
Most-reported reactions
- Drug Hypersensitivity — 5 reports (13.51%)
- Headache — 5 reports (13.51%)
- Diarrhoea — 4 reports (10.81%)
- Myocardial Infarction — 4 reports (10.81%)
- Pain In Extremity — 4 reports (10.81%)
- Decreased Appetite — 3 reports (8.11%)
- Drug Interaction — 3 reports (8.11%)
- Intestinal Diaphragm Disease — 3 reports (8.11%)
- Nausea — 3 reports (8.11%)
- Pneumonia — 3 reports (8.11%)
FENOPROFEN CALCIUM in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is FENOPROFEN CALCIUM approved in United States?
Yes. FDA authorised it on 20 April 1988; FDA authorised it on 2 May 1988; FDA authorised it on 8 June 1988.
Who is the marketing authorisation holder for FENOPROFEN CALCIUM in United States?
DAVA PHARMS INC holds the US marketing authorisation.