Regulatory PathRegulatory requirements compared

Active substance

Clonidine

Open in the medicines table

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

ProductStrengthForm · routeApplicantStatusFirst approved
CATAPRES-TTS-10.1MG/24HRsystem · transdermalLAVIPHARMPrescription10 Oct 1984
CATAPRES-TTS-20.2MG/24HRsystem · transdermalLAVIPHARMPrescription10 Oct 1984
CATAPRES-TTS-30.3MG/24HRsystem · transdermalLAVIPHARMPrescription10 Oct 1984
CLONIDINE HYDROCHLORIDE0.1MGtablet · oralACTAVIS ELIZABETHPrescription16 Dec 1986
CLONIDINE HYDROCHLORIDE0.2MGtablet · oralACTAVIS ELIZABETHPrescription16 Dec 1986
CLONIDINE HYDROCHLORIDE0.3MGtablet · oralACTAVIS ELIZABETHPrescription16 Dec 1986
CLONIDINE HYDROCHLORIDE0.3MG; 0.2MG; 0.1MG; 0.05MGtablet · oralTP ANDA HOLDINGSPrescription4 Sep 1987
CLONIDINE HYDROCHLORIDE0.3MG; 0.1MG; 0.2MGtablet · oralCHARTWELL MOLECULESPrescription5 Apr 1988
CLONIDINE HYDROCHLORIDE0.2MG; 0.1MG; 0.3MGtablet · oralAUROBINDO PHARMA LTDPrescription31 Aug 1988
DURACLON1MG/10ML (0.1MG/ML)injectable · injectionMYLAN INSTITUTIONALPrescription2 Oct 1996
CLONIDINE HYDROCHLORIDE0.1MG; 0.2MG; 0.3MGtablet · oralPRINSTON INCPrescription9 Mar 2007
CLONIDINE HYDROCHLORIDE0.1MG; 0.2MG; 0.3MGtablet · oralUNICHEMPrescription26 Aug 2009
CLONIDINE HYDROCHLORIDE0.1MG; 0.2MG; 0.3MGtablet · oralIMPAX LABSPrescription27 Aug 2009
NEXICLON XREQ 0.17MG BASEtablet, extended release · oralROSEMONT PHARMACEUTICALS LLCPrescription3 Dec 2009
CLONIDINE0.1MG/24HR; 0.2MG/24HR; 0.3MG/24HRsystem · transdermalMYLAN TECHNOLOGIESPrescription16 Jul 2010
CLONIDINE0.1MG/24HR; 0.2MG/24HR; 0.3MG/24HRsystem · transdermalDR REDDYS LABS SAPrescription20 Aug 2010
CLONIDINE HYDROCHLORIDE1MG/10ML (0.1MG/ML); 5MG/10ML (0.5MG/ML)injectable · injectionHIKMA FARMACEUTICAPrescription26 Jan 2011
CLONIDINE HYDROCHLORIDE1MG/10ML (0.1MG/ML); 5MG/10ML (0.5MG/ML)injectable · injectionFRESENIUS KABI USAPrescription8 Jul 2011
CLONIDINE HYDROCHLORIDE0.1MG; 0.2MG; 0.3MG; 0.05MGtablet · oralALEMBIC PHARMS LTDPrescription6 Dec 2011
CLONIDINE HYDROCHLORIDE0.1MG; 0.2MG; 0.3MGtablet · oralYUNG SHIN PHARMPrescription13 Jun 2013
CLONIDINE HYDROCHLORIDE1MG/10ML (0.1MG/ML); 5MG/10ML (0.5MG/ML)injectable · injectionXGEN PHARMSPrescription29 Oct 2013
CLONIDINE HYDROCHLORIDE1MG/10ML (0.1MG/ML); 5MG/10ML (0.5MG/ML)injectable · injectionZYDUS PHARMSPrescription20 Feb 2014
CLONIDINE0.1MG/24HR; 0.2MG/24HR; 0.3MG/24HRsystem · transdermalACTAVIS LABS UT INCPrescription6 May 2014
CLONIDINE HYDROCHLORIDE0.1MGtablet, extended release · oralACTAVIS ELIZABETHPrescription15 May 2015
CLONIDINE HYDROCHLORIDE0.1MGtablet, extended release · oralCHARTWELL RXPrescription23 Oct 2017

48 more — full table

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
CLONIDINE025384900.1 MGTABLET · ORALSIVEM PHARMACEUTICALS ULC
CLONIDINE025385040.2 MGTABLET · ORALSIVEM PHARMACEUTICALS ULC
CLONIDINE025400610.025 MGTABLET · ORALSIVEM PHARMACEUTICALS ULC
JAMP CLONIDINE025282070.025 MGTABLET · ORALJAMP PHARMA CORPORATION
MAR-CLONIDINE025241980.025 MGTABLET · ORALMARCAN PHARMACEUTICALS INC
MINT-CLONIDINE024621920.1 MGTABLET · ORALMINT PHARMACEUTICALS INC
MINT-CLONIDINE024622060.2 MGTABLET · ORALMINT PHARMACEUTICALS INC
MINT-CLONIDINE025347380.025 MGTABLET · ORALMINT PHARMACEUTICALS INC
SANDOZ CLONIDINE025157840.1 MGTABLET · ORALSANDOZ CANADA INCORPORATED
SANDOZ CLONIDINE025157920.2 MGTABLET · ORALSANDOZ CANADA INCORPORATED
SANDOZ CLONIDINE025162170.025 MGTABLET · ORALSANDOZ CANADA INCORPORATED
TEVA-CLONIDINE020461210.1 MGTABLET · ORALTEVA CANADA LIMITED
TEVA-CLONIDINE020461480.2 MGTABLET · ORALTEVA CANADA LIMITED
TEVA-CLONIDINE023041630.025 MGTABLET · ORALTEVA CANADA LIMITED

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACCLONIDINE 0.1 MG/DAY PATCH$6.64381per EA30 Sep 2026
US NADACCLONIDINE 0.2 MG/DAY PATCH$9.04585per EA23 Sep 2026
US NADACCLONIDINE 0.3 MG/DAY PATCH$12.29116per EA30 Sep 2026
US NADACCLONIDINE HCL 0.1 MG TABLET$0.02411per EA23 Sep 2026
US NADACCLONIDINE HCL 0.2 MG TABLET$0.03299per EA23 Sep 2026
US NADACCLONIDINE HCL 0.3 MG TABLET$0.04075per EA23 Sep 2026
US NADACCLONIDINE HCL ER 0.1 MG TABLET$0.21173per EA23 Sep 2026
US NADACCLONIDINE HCL ER 0.17 MG TAB$15.23568per EA23 Sep 2026
US NADACJAVADIN 0.02 MG/ML SOLUTION$1.52934per ML23 Sep 2026
NHS Drug TariffClonidine 100microgram tablets£10.05100 tablet1 Oct 2026
NHS Drug TariffClonidine 150micrograms/1ml solution for injection ampoules£4.185 ampoule1 Oct 2026
NHS Drug TariffClonidine 25microgram tablets£4.05112 tablet1 Oct 2026
NHS Drug TariffClonidine 50micrograms/5ml oral solution sugar free£197.91100 ml1 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 clonidine →

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.