Regulatory PathRegulatory requirements compared

Active substance

Dicycloverine

Open in the medicines table

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

ProductStrengthForm · routeApplicantStatusFirst approved
DICYCLOMINE HYDROCHLORIDE10MGcapsule · oralLANNETTPrescription30 Sep 1974
DICYCLOMINE HYDROCHLORIDE10MGcapsule · oralWATSON LABSPrescription28 Jul 1976
DICYCLOMINE HYDROCHLORIDE20MGtablet · oralWATSON LABSPrescription17 Aug 1976
DICYCLOMINE HYDROCHLORIDE20MGtablet · oralHIKMA PHARMSPrescription1 Oct 1996
DICYCLOMINE HYDROCHLORIDE10MGcapsule · oralWEST WARDPrescription28 Feb 1997
DICYCLOMINE HYDROCHLORIDE20MGtablet · oralLANNETTPrescription26 Feb 1999
DICYCLOMINE HYDROCHLORIDE20MGtablet · oralAUROBINDO PHARMA USAPrescription7 Sep 1999
DICYCLOMINE HYDROCHLORIDE10MGcapsule · oralAUROBINDO PHARMA USAPrescription7 Sep 1999
DICYCLOMINE HYDROCHLORIDE (PRESERVATIVE FREE)10MG/MLinjectable · injectionHIKMA PHARMSPrescription30 Jun 2003
DICYCLOMINE HYDROCHLORIDE10MG/5MLsyrup · oralPH HEALTHPrescription24 Mar 2005
DICYCLOMINE HYDROCHLORIDE10MG/MLinjectable · injectionAM REGENTPrescription17 Feb 2017
DICYCLOMINE HYDROCHLORIDE10MG/MLinjectable · injectionFOSUN PHARMAPrescription2 Jul 2018
DICYCLOMINE HYDROCHLORIDE10MG/MLinjectable · injectionSLATE RUN PHARMAPrescription2 Nov 2018
DICYCLOMINE HYDROCHLORIDE10MG/MLinjectable · injectionFRESENIUS KABI USAPrescription25 Jan 2019
DICYCLOMINE HYDROCHLORIDE10MG/5MLsyrup · oralHIKMA PHARMSPrescription22 May 2020
DICYCLOMINE HYDROCHLORIDE10MG/5MLsyrup · oralNOVITIUM PHARMAPrescription23 Apr 2021
DICYCLOMINE HYDROCHLORIDE20MGtablet · oralCOREPHARMAPrescription28 Nov 2022
DICYCLOMINE HYDROCHLORIDE20MG; 40MGtablet · oralRUBICON RESEARCHPrescription14 Dec 2022
DICYCLOMINE HYDROCHLORIDE10MGcapsule · oralTWI PHARMSPrescription27 Dec 2022
DICYCLOMINE HYDROCHLORIDE10MGcapsule · oralCOREPHARMAPrescription24 Mar 2023
DICYCLOMINE HYDROCHLORIDE20MGtablet · oralTWI PHARMSPrescription1 Jun 2023
DICYCLOMINE HYDROCHLORIDE20MGtablet · oralBIONPHARMAPrescription4 Aug 2023
DICYCLOMINE HYDROCHLORIDE10MGcapsule · oralPRINSTON INCPrescription30 Aug 2023
DICYCLOMINE HYDROCHLORIDE20MGtablet · oralANNORA PHARMAPrescription7 May 2024
DICYCLOMINE HYDROCHLORIDE10MGcapsule · oralANNORA PHARMAPrescription1 Jul 2024

23 more — full table

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
JAMP-DICYCLOMINE HCL0236608820 MGTABLET · ORALJAMP PHARMA CORPORATION
JAMP-DICYCLOMINE HCL0239161910 MGTABLET · ORALJAMP PHARMA CORPORATION
RIVA-DICYCLOMINE0055710210 MGCAPSULE · ORALLABORATOIRE RIVA INC.

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACDICYCLOMINE 10 MG CAPSULE$0.07775per EA23 Sep 2026
US NADACDICYCLOMINE 10 MG/5 ML SOLN$0.17356per ML23 Sep 2026
US NADACDICYCLOMINE 20 MG TABLET$0.059per EA23 Sep 2026
NHS Drug TariffDicycloverine 10mg tablets£8.93100 tablet1 Oct 2026
NHS Drug TariffDicycloverine 10mg/5ml oral solution£174.11120 ml1 Oct 2026
NHS Drug TariffDicycloverine 20mg tablets£9.2884 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.