Regulatory PathRegulatory requirements compared

Active substance

Trandolapril

Open in the medicines table

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

ProductStrengthForm · routeApplicantStatusFirst approved
TRANDOLAPRIL1MG; 2MG; 4MGtablet · oralLUPINPrescription12 Jun 2007
TRANDOLAPRIL1MG; 2MG; 4MGtablet · oralAUROBINDO PHARMAPrescription12 Jun 2007
TRANDOLAPRIL2MG; 4MG; 1MGtablet · oralEPIC PHARMAPrescription18 Jun 2008
MAVIK1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**tablet · oralABBVIEDiscontinued26 Apr 1996
TRANDOLAPRIL1MG; 2MG; 4MGtablet · oralTEVA PHARMSDiscontinued12 Dec 2006
TRANDOLAPRIL1MG; 2MG; 4MGtablet · oralEPIC PHARMA LLCDiscontinued12 Jun 2007
TRANDOLAPRIL2MG; 1MG; 4MGtablet · oralCHARTWELL MOLECULARDiscontinued12 Jun 2007
TRANDOLAPRIL1MG; 2MG; 4MGtablet · oralWATSON LABSDiscontinued12 Jun 2007
TRANDOLAPRIL1MG; 2MG; 4MGtablet · oralINVAGEN PHARMSDiscontinued12 Jun 2007
TRANDOLAPRIL1MG; 2MG; 4MGtablet · oralPHARMOBEDIENTDiscontinued28 Apr 2008
TRANDOLAPRIL1MG; 2MG; 4MGtablet · oralPHARMAZONEDiscontinued25 Aug 2008

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
AURO-TRANDOLAPRIL024718680.5 MGCAPSULE · ORALAURO PHARMA INC
AURO-TRANDOLAPRIL024718761 MGCAPSULE · ORALAURO PHARMA INC
AURO-TRANDOLAPRIL024718842 MGCAPSULE · ORALAURO PHARMA INC
AURO-TRANDOLAPRIL024718924 MGCAPSULE · ORALAURO PHARMA INC
MAVIK022314570.5 MGCAPSULE · ORALBGP PHARMA ULC
MAVIK022314591 MGCAPSULE · ORALBGP PHARMA ULC
MAVIK022314602 MGCAPSULE · ORALBGP PHARMA ULC
MAVIK022392674 MGCAPSULE · ORALBGP PHARMA ULC
PMS-TRANDOLAPRIL023577550.5 MGCAPSULE · ORALPHARMASCIENCE INC
PMS-TRANDOLAPRIL023577631 MGCAPSULE · ORALPHARMASCIENCE INC
PMS-TRANDOLAPRIL023577712 MGCAPSULE · ORALPHARMASCIENCE INC
PMS-TRANDOLAPRIL023577984 MGCAPSULE · ORALPHARMASCIENCE INC
SANDOZ TRANDOLAPRIL023257210.5 MGCAPSULE · ORALSANDOZ CANADA INCORPORATED
SANDOZ TRANDOLAPRIL023257481 MGCAPSULE · ORALSANDOZ CANADA INCORPORATED
SANDOZ TRANDOLAPRIL023257562 MGCAPSULE · ORALSANDOZ CANADA INCORPORATED
SANDOZ TRANDOLAPRIL023257644 MGCAPSULE · ORALSANDOZ CANADA INCORPORATED
TRANDOLAPRIL024886981 MGCAPSULE · ORALPRO DOC LIMITEE
TRANDOLAPRIL024887012 MGCAPSULE · ORALPRO DOC LIMITEE
TRANDOLAPRIL024887284 MGCAPSULE · ORALPRO DOC LIMITEE
TRANDOLAPRIL025250461 MGCAPSULE · ORALSANIS HEALTH INC
TRANDOLAPRIL025250542 MGCAPSULE · ORALSANIS HEALTH INC
TRANDOLAPRIL025250704 MGCAPSULE · ORALSANIS HEALTH INC
TRANDOLAPRIL025265651 MGCAPSULE · ORALSIVEM PHARMACEUTICALS ULC
TRANDOLAPRIL025265732 MGCAPSULE · ORALSIVEM PHARMACEUTICALS ULC
TRANDOLAPRIL025265814 MGCAPSULE · ORALSIVEM PHARMACEUTICALS ULC

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACTRANDOLAPRIL 1 MG TABLET$0.15716per EA23 Sep 2026
US NADACTRANDOLAPRIL 2 MG TABLET$0.16218per EA23 Sep 2026
US NADACTRANDOLAPRIL 4 MG TABLET$0.15608per EA23 Sep 2026
NHS Drug TariffTrandolapril 1mg capsules£17.1628 capsule1 Oct 2026
NHS Drug TariffTrandolapril 2mg capsules£2.9428 capsule1 Oct 2026
NHS Drug TariffTrandolapril 4mg capsules£12.6428 capsule1 Oct 2026
NHS Drug TariffTrandolapril 500microgram capsules£1.6714 capsule1 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 trandolapril →

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.