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:
2017-05-30
Original market date: See footnote 1
2017-05-30
Product name:
NALTREXONE HYDROCHLORIDE TABLETS USP
DIN:
02451883
Product Monograph/Veterinary Labelling:
Date:
2016-02-05
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
STERINOVA INC.
3005 Avenue Jose-Maria Rosell
Saint-Hyacinthe
Quebec
Canada
J2S 0J9
Class:
Human
Dosage form(s):
Tablet
Route(s) of administration:
Oral
Number of active ingredient(s):
1
Schedule(s):
Prescription
American Hospital Formulary Service (AHFS): See footnote 3
28:10.00
Anatomical Therapeutic Chemical (ATC): See footnote 4
N07BB04 NALTREXONE
Active ingredient group (AIG) number:See footnote5
0118591001
Active ingredient(s) See footnote8 | Strength |
---|---|
NALTREXONE HYDROCHLORIDE | 50 MG |