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:
Cancelled Pre Market
Current status date:
2021-07-29
Original market date: See footnote 1
Product name:
TEVA-OLOPATADINE
DIN:
02312832
Product Monograph/Veterinary Labelling:
Date:
2013-01-17
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
TEVA CANADA LIMITED
30 Novopharm Court
Toronto
Ontario
Canada
M1B 2K9
Class:
Human
Dosage form(s):
Solution
Route(s) of administration:
Ophthalmic
Number of active ingredient(s):
1
Schedule(s):
Prescription
American Hospital Formulary Service (AHFS): See footnote 3
52:02.00
Anatomical Therapeutic Chemical (ATC): See footnote 4
S01GX09 OLOPATADINE
Active ingredient group (AIG) number:See footnote5
0132394001
| Active ingredient(s) See footnote8 | Strength |
|---|---|
| OLOPATADINE (OLOPATADINE HYDROCHLORIDE) | 0.1 % / W/V |