Regulatory PathRegulatory requirements compared

Active substance

Pentoxifylline

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
TRENTAL TAB 400MG400 mgProlonged-release tablet · Oral use100 BlisterSAR 99.60NCE · Prescriptionsanofi-aventisValid
TRENTAL TAB 400MG400 mgProlonged-release tablet · Oral use20 BlisterSAR 27.00NCE · Prescriptionsanofi-aventisValid
Indications — CHI Daman Drug Formulary

CHRONIC VENOUS INSUFFICIENCY; SARCOIDOSIS; VARICOSE VEINS

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

ProductStrengthForm · routeApplicantStatusFirst approved
TRENTAL400MGtablet, extended release · oralVALIDUS PHARMSPrescription30 Aug 1984
PENTOXIFYLLINE400MGtablet, extended release · oralRISINGPrescription8 Jul 1997
PENTOXIFYLLINE400MGtablet, extended release · oralANI PHARMSPrescription9 Jul 1997
PENTOXIFYLLINE400MGtablet, extended release · oralAPOTEXPrescription9 Jun 1999
PENTOXIFYLLINE400MGtablet, extended release · oralHERITAGEDiscontinued8 Jul 1997
PENTOXIFYLLINE400MGtablet, extended release · oralBAUSCHDiscontinued20 Jul 1998
PENTOXIFYLLINE400MGtablet, extended release · oralANI PHARMSDiscontinued4 Sep 1998
PENTOXIL400MGtablet, extended release · oralUPSHER SMITH LABSDiscontinued31 Mar 1999
PENTOXIFYLLINE400MGtablet, extended release · oralPLIVADiscontinued25 May 1999
PENTOXIFYLLINE400MGtablet, extended release · oralIMPAX LABSDiscontinued10 Aug 1999
PENTOXIFYLLINE400MGtablet, extended release · oralANI PHARMSDiscontinued3 Sep 1999

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
APO-PENTOXIFYLLINE SR02230090400 MGTABLET (EXTENDED-RELEASE) · ORALAPOTEX INC
JAMP PENTOXIFYLLINE SR02543087400 MGTABLET (EXTENDED-RELEASE) · ORALJAMP PHARMA CORPORATION

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACPENTOXIFYLLINE ER 400 MG TAB$0.22728per EA23 Sep 2026
NHS Drug TariffPentoxifylline 400mg modified-release tablets£19.3990 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.

Safety signals and safety-related labeling changes

All safety entries for pentoxifylline →

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.