Regulatory PathRegulatory requirements compared

Active substance

Fenoprofen

Open in the medicines table

US FDA United States — FDA approvals (Drugs@FDA)

ProductStrengthForm · routeApplicantStatusFirst approved
FENOPROFEN CALCIUMEQ 400MG BASE; EQ 200MG BASE; EQ 300MG BASEcapsule · oralRISINGPrescription18 Jul 2022
FENOPROFEN CALCIUMEQ 200MG BASE; EQ 300MG BASEcapsule · oralMISEMERPrescription16 May 2023
NALFONEQ 300MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; EQ 200MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; EQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**capsule · oralPHARMACODiscontinued16 Mar 1976
NALFONEQ 600MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**tablet · oralDISTADiscontinued9 Jun 1977
FENOPROFEN CALCIUMEQ 600MG BASEtablet · oralDAVA PHARMS INCDiscontinued20 Apr 1988
FENOPROFEN CALCIUMEQ 600MG BASEtablet · oralANI PHARMSDiscontinued2 May 1988
FENOPROFEN CALCIUMEQ 600MG BASEtablet · oralPHARMACODiscontinued8 Jun 1988
FENOPROFEN CALCIUMEQ 600MG BASEtablet · oralWATSON LABS TEVADiscontinued13 Jun 1988
FENOPROFEN CALCIUMEQ 600MG BASEtablet · oralSTRIDES PHARMA INTLDiscontinued19 Jul 1988
FENOPROFEN CALCIUMEQ 200MG BASEcapsule · oralPAR PHARMDiscontinued22 Aug 1988
FENOPROFEN CALCIUMEQ 300MG BASEcapsule · oralPAR PHARMDiscontinued22 Aug 1988
FENOPROFEN CALCIUMEQ 600MG BASEtablet · oralIVAX SUB TEVA PHARMSDiscontinued29 Aug 1988
FENOPROFEN CALCIUMEQ 600MG BASEtablet · oralWATSON LABSDiscontinued11 Oct 1988
FENOPROFEN CALCIUMEQ 300MG BASEcapsule · oralRISINGDiscontinued14 Oct 1988
FENOPROFEN CALCIUMEQ 200MG BASEcapsule · oralRISINGDiscontinued17 Oct 1988
FENOPROFEN CALCIUMEQ 600MG BASEtablet · oralRISINGDiscontinued17 Oct 1988
FENOPROFEN CALCIUMEQ 600MG BASEtablet · oralSUN PHARM INDUSTRIESDiscontinued21 Dec 1990
FENOPROFEN CALCIUMEQ 200MG BASEcapsule · oralWATSON LABSDiscontinued19 Aug 1991
FENOPROFEN CALCIUMEQ 300MG BASEcapsule · oralWATSON LABSDiscontinued19 Aug 1991
FENOPROFEN CALCIUMEQ 400MG BASEcapsule · oralMISEMERDiscontinued16 May 2023
FENOPROFEN CALCIUMEQ 300MG BASEcapsule · oralQUANTUM PHARMICSDiscontinued
FENOPROFEN CALCIUMEQ 600MG BASEtablet · oralWATSON LABSDiscontinued
FENOPROFEN CALCIUMEQ 600MG BASEtablet · oralQUANTUM PHARMICSDiscontinued
FENOPROFEN CALCIUMEQ 200MG BASEcapsule · oralQUANTUM PHARMICSDiscontinued
FENOPROFEN CALCIUMEQ 300MG BASEcapsule · oralWATSON LABSDiscontinued

10 more — full table

Safety signals and safety-related labeling changes

  • US FDA 21 Nov 2024 NALFON — safety-related labeling change
    Labeling sections changed: Boxed Warning; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for fenoprofen →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.