Product information
From Health Canada
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:
2012-03-19
Original market date: See footnote 1
2012-03-19
Product name:
DURELA
DIN:
02373033
Product Monograph/Veterinary Labelling:
Date:
2022-03-03
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
CIPHER PHARMACEUTICALS INC
404
5750 Explorer Drive
Mississauga
Ontario
Canada
L4W 0A9
Class:
Human
Dosage form(s):
Capsule (Extended Release)
Route(s) of administration:
Oral
Number of active ingredient(s):
1
Schedule(s):
Narcotic (CDSA I)
American Hospital Formulary Service (AHFS): See footnote 3
28:08.08
Anatomical Therapeutic Chemical (ATC): See footnote 4
N02AX02 TRAMADOL
Active ingredient group (AIG) number:See footnote5
0151694001
| Active ingredient(s) See footnote8 | Strength |
|---|---|
| TRAMADOL HYDROCHLORIDE | 300 MG |
Risk Management Plans See footnote 7
A Canadian Specific Opioid targeted Risk Management Plan (CSO-tRMP) for this product was submitted.