Regulatory PathRegulatory requirements compared

Active substance

Carbinoxamine

Open in the medicines table

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

ProductStrengthForm · routeApplicantStatusFirst approved
CARBINOXAMINE MALEATE4MG/5MLsolution · oralGENUSPrescription25 Apr 2003
CARBINOXAMINE MALEATE4MGtablet · oralSTRIDES PHARMA INTLPrescription30 May 2008
CARBINOXAMINE MALEATE4MGtablet · oralMISSION PHARMACALPrescription27 May 2011
KARBINAL ER4MG/5MLsuspension, extended release · oralAYTUPrescription28 Mar 2013
CARBINOXAMINE MALEATE6MGtablet · oralPHARMOBEDIENTPrescription31 May 2016
CARBINOXAMINE MALEATE6MGtablet · oralLEADINGPrescription19 Dec 2024
CARBINOXAMINE MALEATE4MGtablet · oralGENUS LIFESCIENCESDiscontinued19 Mar 2003
CARBINOXAMINE MALEATE4MG/5MLsolution · oralPH HEALTHDiscontinued26 Feb 2008
CARBINOXAMINE MALEATE4MGtablet · oralSTRIDES PHARMA INTLDiscontinued30 May 2008
CARBINOXAMINE MALEATE4MGtablet · oralSENORES PHARMSDiscontinued15 Apr 2010
CARBINOXAMINE MALEATE4MG/5MLsolution · oralCYPRESS PHARMDiscontinued4 May 2010
CARBINOXAMINE MALEATE4MGtablet · oralCYPRESS PHARMDiscontinued23 Aug 2010
CLISTIN4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**tablet · oralORTHO MCNEIL PHARMDiscontinued
CLISTIN4MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**elixir · oralMCNEILDiscontinued

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACCARBINOXAMINE ER 4 MG/5 ML SUSP$1.04689per ML23 Sep 2026
US NADACCARBINOXAMINE MALEATE 4 MG TAB$0.39806per 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.

Safety signals and safety-related labeling changes

  • US FDA 25 Mar 2021 KARBINAL ER — safety-related labeling change
    Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for carbinoxamine →

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.