Regulatory PathRegulatory requirements compared

Active substance

Etodolac

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
LODINE 300MG CAPS300 mgCapsule, soft · Oral use30 BlisterSAR 62.40NCE · PrescriptionWYETHWithdrawn by MAH · Not Marketed

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

ProductStrengthForm · routeApplicantStatusFirst approved
ETODOLAC400MG; 500MGtablet · oralPANGEAPrescription11 Apr 1997
ETODOLAC400MG; 500MGtablet · oralTARO PHARM INDSPrescription11 Mar 1998
ETODOLAC200MG; 300MGcapsule · oralTAROPrescription30 Apr 1998
ETODOLAC200MG; 300MGcapsule · oralANI PHARMSPrescription16 Sep 1999
ETODOLAC200MG; 300MGcapsule · oralAPOTEXPrescription28 Jul 2000
ETODOLAC600MG; 500MG; 400MGtablet, extended release · oralTEVAPrescription31 Jul 2000
ETODOLAC400MG; 500MGtablet · oralAPOTEXPrescription3 Dec 2002
ETODOLAC400MG; 500MG; 600MGtablet, extended release · oralTAROPrescription13 Mar 2003
ETODOLAC400MG; 500MG; 600MGtablet, extended release · oralZYDUS PHARMSPrescription23 Jan 2014
ETODOLAC400MG; 500MGtablet · oralAMNEAL PHARMS COPrescription7 Jun 2018
ETODOLAC400MG; 500MGtablet · oralADAPTISPrescription30 Nov 2018
ETODOLAC400MG; 500MG; 600MGtablet, extended release · oralUNICHEMPrescription24 Nov 2020
ETODOLAC400MG; 500MGtablet · oralIPCA LABS LTDPrescription1 May 2024
ETODOLAC200MG; 300MGcapsule · oralIPCA LABS LTDPrescription1 Aug 2024
ETODOLAC400MG; 500MGtablet · oralAUROBINDO PHARMA LTDPrescription15 Jul 2026
LODINE200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 300MGcapsule · oralWYETH PHARMS INCDiscontinued31 Jan 1991
LODINE400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**tablet · oralWYETH PHARMS INCDiscontinued31 Jan 1991
LODINE XL400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 600MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**tablet, extended release · oralWYETH PHARMS INCDiscontinued25 Oct 1996
ETODOLAC400MG; 500MGtablet · oralTP ANDA HOLDINGSDiscontinued28 Feb 1997
ETODOLAC400MGtablet · oralSHREE HARI INTLDiscontinued28 Feb 1997
ETODOLAC400MG; 500MGtablet · oralIVAX SUB TEVA PHARMSDiscontinued28 Feb 1997
ETODOLAC400MG; 500MGtablet · oralWATSON LABSDiscontinued16 Apr 1997
ETODOLAC200MG; 300MGcapsule · oralNATCO PHARMADiscontinued16 May 1997
ETODOLAC400MGtablet · oralCHARTWELL MOLECULESDiscontinued27 Jun 1997
ETODOLAC200MG; 300MGcapsule · oralANI PHARMSDiscontinued8 Jul 1997

18 more — full table

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACETODOLAC 200 MG CAPSULE$0.29637per EA23 Sep 2026
US NADACETODOLAC 300 MG CAPSULE$0.41563per EA23 Sep 2026
US NADACETODOLAC 400 MG TABLET$0.26236per EA23 Sep 2026
US NADACETODOLAC 500 MG TABLET$0.28517per EA23 Sep 2026
US NADACETODOLAC ER 400 MG TABLET$0.61584per EA23 Sep 2026
US NADACETODOLAC ER 500 MG TABLET$0.71762per EA23 Sep 2026
US NADACETODOLAC ER 600 MG TABLET$1.07277per EA23 Sep 2026
NHS Drug TariffEtodolac 600mg modified-release tablets£18.5830 tablet1 Oct 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

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.