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:
2023-10-30
Original market date: See footnote 1
2023-10-30
Product name:
PRO-ZOLPIDEM ODT
DIN:
02537354
Product Monograph/Veterinary Labelling:
Date:
2023-04-20
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
PRO DOC LIMITEE
2925 Boulevard Industriel
Laval
Quebec
Canada
H7L 3W9
Class:
Human
Dosage form(s):
Tablet (Orally Disintegrating)
Route(s) of administration:
Sublingual
Number of active ingredient(s):
1
Schedule(s):
Targeted (CDSA IV)
American Hospital Formulary Service (AHFS): See footnote 3
28:24.92
Anatomical Therapeutic Chemical (ATC): See footnote 4
N05CF02 ZOLPIDEM
Active ingredient group (AIG) number:See footnote5
0122857002
| Active ingredient(s) See footnote8 | Strength |
|---|---|
| ZOLPIDEM TARTRATE | 10 MG |