Regulatory PathRegulatory requirements compared

Active substance

Benzatropine

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
Benztropine Mesylate Injection USP1 mg/mlSolution for injection · Intramuscular and intravenous use5 VialSAR 279.15Generic · PrescriptionNavinta LLCValid

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

ProductStrengthForm · routeApplicantStatusFirst approved
BENZTROPINE MESYLATE0.5MGtablet · oralPLIVAPrescription10 Aug 1988
BENZTROPINE MESYLATE1MGtablet · oralPLIVAPrescription10 Aug 1988
BENZTROPINE MESYLATE2MGtablet · oralPLIVAPrescription10 Aug 1988
BENZTROPINE MESYLATE0.5MGtablet · oralEPIC PHARMA LLCPrescription27 Feb 1989
BENZTROPINE MESYLATE1MGtablet · oralEPIC PHARMA LLCPrescription27 Feb 1989
BENZTROPINE MESYLATE2MGtablet · oralEPIC PHARMA LLCPrescription27 Feb 1989
BENZTROPINE MESYLATE2MG; 1MG; 0.5MGtablet · oralCHARTWELL RXPrescription23 Jan 1992
BENZTROPINE MESYLATE0.5MG; 1MG; 2MGtablet · oralAIPING PHARM INCPrescription12 Dec 1996
BENZTROPINE MESYLATE0.5MG; 1MG; 2MGtablet · oralPH HEALTHPrescription27 Aug 2007
BENZTROPINE MESYLATE1MG/MLinjectable · injectionFRESENIUS KABI USAPrescription28 Jul 2009
BENZTROPINE MESYLATE1MG/MLinjectable · injectionHIKMA FARMACEUTICAPrescription31 Aug 2009
BENZTROPINE MESYLATE0.5MG; 1MG; 2MGtablet · oralLEADINGPrescription28 Nov 2012
BENZTROPINE MESYLATE1MG/MLinjectable · injectionNAVINTA LLCPrescription5 Feb 2013
BENZTROPINE MESYLATE0.5MG; 1MG; 2MGtablet · oralNUVO PHARMPrescription14 Apr 2015
BENZTROPINE MESYLATE1MG/MLinjectable · injectionHIKMAPrescription14 Oct 2021
BENZTROPINE MESYLATE0.5MG; 1MG; 2MGtablet · oralQUAGENPrescription11 Feb 2025
COGENTIN2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**tablet · oralMERCKDiscontinued5 Mar 1954
COGENTIN1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**injectable · injectionEPIC PHARMA LLCDiscontinued21 Dec 1959
BENZTROPINE MESYLATE0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**tablet · oralLANNETT CO INCDiscontinued11 Apr 1985
BENZTROPINE MESYLATE1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**tablet · oralLANNETT CO INCDiscontinued11 Apr 1985
BENZTROPINE MESYLATE2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**tablet · oralLANNETT CO INCDiscontinued11 Apr 1985
BENZTROPINE MESYLATE2MG; 0.5MG; 1MGtablet · oralTP ANDA HOLDINGSDiscontinued14 Feb 2008
BENZTROPINE MESYLATE0.5MG; 1MG; 2MGtablet · oralINVAGEN PHARMSDiscontinued29 Mar 2010
BENZTROPINE MESYLATE1MG/MLinjectable · injectionLUITPOLDDiscontinued29 Mar 2010
BENZTROPINE MESYLATE1MGtablet · oralQUANTUM PHARMICSDiscontinued

5 more — full table

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
BENZTROPINE OMEGA022389031 MG / MLLIQUID · INTRAMUSCULAR; INTRAVENOUSOMEGA LABORATORIES LIMITED
PDP-BENZTROPINE007065311 MGTABLET · ORALPENDOPHARM DIVISION OF PHARMASCIENCE INC

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACBENZTROPINE MES 0.5 MG TAB$0.06474per EA23 Sep 2026
US NADACBENZTROPINE MES 1 MG TABLET$0.0753per EA23 Sep 2026
US NADACBENZTROPINE MES 2 MG TABLET$0.09059per EA23 Sep 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.