Dexchlorpheniramine maleate

Overview

Dexchlorpheniramine is the S-enantiomer of chlorpheniramine which is a 1st generation anti-histamine. Dexchlorpheniramine has more pharmacological activity than the R and so is more potent than the racemic mixture.

Indication

Dexchlorpheniramine can be used in the treatment of perennial and seasonal allergic rhinitis, vasomotor rhiniti, allergic conjunctivitis due to inhalant allergens and foods, mild uncomplicated allergic skin manifestations of urticaria and angioedema, amelioration of allergic reactions to blood or plasma, and dermographism.

Associated Conditions

Allergic Conjunctivitis (AC)
Allergic Reaction
Allergic Rhinitis (AR)
Angioedema
Common Cold
Dermographism
Urticaria
Vasomotor Rhinitis

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor

No clinical trials found

No clinical trials found for this drug

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
POLMON	Capellon Pharmaceuticals, LLC	64543-600	ORAL	2 mg in 5 mL	8/21/2023
RYCLORA	CARWIN PHARMACEUTICAL ASSOCIATES, LLC	15370-150	ORAL	2 mg in 5 mL	1/8/2024

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
AXCEL DEXCHLORPHENIRAMINE FORTE SYRUP 2 mg/5 ml	KOTRA PHARMA (M) SDN BHD	SIN10542P	SYRUP	2 mg/5 ml	12/11/1998
POLARINE SYRUP	SUNWARD PHARMACEUTICAL PRIVATE LIMITED, SUNWARD PHARMACEUTICAL SDN BHD	SIN03182P	SYRUP	2 mg/5 ml	5/31/1989
PAEDICOF SYRUP (Revised Formula)	SUNWARD PHARMACEUTICAL PRIVATE LIMITED	SIN11515P	SYRUP	1 mg/5 ml	5/15/2001
DEXTRAMINE TABLET 2 mg	CHULIA PHARMA SDN BHD	SIN09373P	TABLET	2 mg	6/13/1997
POLARAX SYRUP 2 mg/5 ml	SUNWARD PHARMACEUTICAL PRIVATE LIMITED	SIN02491P	SYRUP	2 mg/5 ml	3/6/1989
MENDICOF SYRUP (Revised Formula)	SUNWARD PHARMACEUTICAL PRIVATE LIMITED	SIN11516P	SYRUP	2 mg/5 ml	5/15/2001
DEXCHLORAMINE TABLET 2 mg	BEACONS PHARMACEUTICALS PTE. LTD.	SIN02655P	TABLET	2 mg	4/27/1989
SOMIN TAB 2 mg	Y S P INDUSTRIES (M) SDN BHD	SIN09916P	TABLET	2 mg	7/30/1998
POLARINE TABLET	SUNWARD PHARMACEUTICAL PRIVATE LIMITED, SUNWARD PHARMACEUTICAL SDN BHD	SIN07612P	TABLET	2 mg	1/18/1994
POLARAX TABLET 2 mg	SUNWARD PHARMACEUTICAL PRIVATE LIMITED, SUNWARD PHARMACEUTICAL SDN BHD	SIN09125P	TABLET	2 mg	1/13/1997

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
DEXTROMINE-8 SYRUP 8MG/5ML	N/A	NEOCHEM PHARMACEUTICAL LABORATORIES LIMITED	N/A	N/A	11/8/1995
ZOCON TAB	N/A	EUROPHARM LABORATOIRES COMPANY LIMITED	N/A	N/A	2/15/2008
SYNBETAMINE TABLETS (PINK)	N/A	synco (h.k.) limited	N/A	N/A	6/29/2017
BETARON CAP	N/A	MEYER BPC PHARMACEUTICALS LIMITED	N/A	N/A	12/6/1994
PAKABOL COUGH SYRUP	N/A	ADVANCE PHARMACEUTICAL COMPANY LIMITED	N/A	N/A	11/29/2000
GOLDEN CUP COUGH SYRUP	N/A	ADVANCE PHARMACEUTICAL COMPANY LIMITED	N/A	N/A	8/18/2000
DELAMIN TAB 2MG	N/A	Kai Yuen Pharmaceutical Co	N/A	N/A	3/25/2004
PHENACOLL COUGH SYRUP	N/A	ADVANCE PHARMACEUTICAL COMPANY LIMITED	N/A	N/A	8/18/2000
VIDAMINE SYRUP	N/A	MARCHING PHARMACEUTICAL LIMITED	N/A	N/A	9/14/2009
DEXCHLORAMINE TABLETS 2MG	N/A	VAST RESOURCES PHARMACEUTICAL LIMITED	N/A	N/A	3/12/2025

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
TERRYWHITE CHEMMART DEXCHLORPHENIRAMINE ALLERGY dexchlorpheniramine maleate 2 mg tablet blister pack	460388	Maple Healthcare Pty Ltd	Medicine	A	8/22/2024
MAPLE DEXCHLORPHENIRAMINE ALLERGY dexchlorpheniramine maleate 2mg tablet blister pack	406909	Maple Healthcare Pty Ltd	Medicine	A	3/27/2023
POLARGEN Dexchlorpheniramine maleate 2 mg tablet blister pack	378074	Bioinnova Pty Ltd	Medicine	A	11/16/2021
PHARMACY ACTION POLARELIEF dexchlorpheniramine maleate 2 mg tablet blister pack	372472	Generic Health Pty Ltd	Medicine	A	8/9/2021
SAGA DEXCHLORPHENIRAMINE ALLERGY dexchlorpheniramine maleate 2mg tablet blister pack	407490	Saga Lifesciences Australia Pty Ltd	Medicine	A	4/11/2023
APOHEALTH DEXCHLORPHENIRAMINE ALLERGY RELIEF dexchlorpheniramine maleate 2 mg tablet blister pack	453936	Metina Australia Pty Ltd	Medicine	A	6/28/2024
POLAHIST Dexchlorpheniramine maleate 2 mg tablet blister pack	378072	Bioinnova Pty Ltd	Medicine	A	11/16/2021
POLARAMINE dexchlorpheniramine maleate 0.4mg/mL syrup bottle	18197	Bayer Australia Ltd	Medicine	A	10/8/1991
POLARAMINE TABLETS dexchlorpheniramine maleate 2 mg blister pack	154653	Bayer Australia Ltd	Medicine	A	8/18/2008
ALLERCLEAR dexchlorpheniramine maleate 2 mg tablets blister pack	348212	AFT Pharmaceuticals Pty Ltd	Medicine	A	11/12/2020

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
POLARAMINE TAB 2MG	schering-plough canada inc	00028207	Tablet - Oral	2 MG	12/31/1959
POLARAMINE REPETABS 6MG	schering-plough canada inc	00176893	Tablet (Extended-Release) - Oral	6 MG / TAB	12/31/1958

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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