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The product monograph is developed by a drug sponsor according to guidelines published by Health Canada that provide direction on the content and format. The veterinary labelling is developed by the drug sponsor according to the Food and Drug Regulations. While Health Canada reviews the product monograph or the veterinary labelling as part of the drug review process, it remains the responsibility of the drug sponsor to ensure that the product monograph or the veterinary labelling is complete and accurate.

Current status:

Marketed

Current status date:

2016-09-07

Original market date: See footnote 1

2013-03-21

Product name:

EDARBYCLOR

Help on accessing alternative formats, such as Portable Document Format (PDF), Microsoft Word and PowerPoint (PPT) files, can be obtained in the alternate format help section .

DIN:

02397749

Product Monograph/Veterinary Labelling:

Date: 2016-09-15 Product monograph/Veterinary Labelling (PDF version ~ 175K)

Company: 

VALEANT CANADA LP/VALEANT CANADA S.E.C.
2150 Boul. St-Elzear Ouest
Laval
Quebec
Canada  H7L 4A8

Class: 

Human

Dosage form(s):

Tablet

Route(s) of administration:

Oral

Number of active ingredient(s):

2

Schedule(s):

Prescription  

Biosimilar Biologic Drug:

No

American Hospital Formulary Service (AHFS): See footnote 3

40:28.24   THIAZIDE-LIKE DIURETICS ,  24:32.08   ANGIOTENSIN II RECEPTOR ANTAGONISTS

Anatomical Therapeutic Chemical (ATC): See footnote 4

C09DA09  AZILSARTANT MEDOXIMIL AND DIURETICS

Active ingredient group (AIG) number:See footnote 5

0253470002

List of active ingredient(s)
Active ingredient(s) Strength
AZILSARTAN MEDOXOMIL (AZILSARTAN MEDOXOMIL POTASSIUM) 40 MG
CHLORTHALIDONE 12.5 MG

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