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:
2020-10-21
Original market date: See footnote 1
2020-10-21
Product name:
ACH-QUETIAPINE FUMARATE XR
DIN:
02450879
Product Monograph/Veterinary Labelling:
Date:
2022-02-09
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
ACCORD HEALTHCARE INC
3535 Boulevard St-Charles, Suite 704
Kirkland
Quebec
Canada
H9H 5B9
Class:
Human
Dosage form(s):
Tablet (Extended-Release)
Route(s) of administration:
Oral
Number of active ingredient(s):
1
Schedule(s):
Prescription
American Hospital Formulary Service (AHFS): See footnote 3
28:16.08.04
Anatomical Therapeutic Chemical (ATC): See footnote 4
N05AH04 QUETIAPINE
Active ingredient group (AIG) number:See footnote5
0131858004
| Active ingredient(s) See footnote8 | Strength |
|---|---|
| QUETIAPINE (QUETIAPINE FUMARATE) | 150 MG |