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 Post Market
Current status date:
2012-07-05
Original market date: See footnote 1
2009-08-20
Product name:
ONDANSETRON INJECTION, USP
Description:
WITH PRESERVATIVE, MULTIDOSE VIAL
DIN:
02322668
Product Monograph/Veterinary Labelling:
Date:
2012-04-11
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
AGILA SPECIALTIES PRIVATE LIMITED
Strides House, Opp.Iim, Bilekahalli, Bannerghatta Road
Bangalore
Karnataka
India
560076
Class:
Human
Dosage form(s):
Solution
Route(s) of administration:
Intravenous
Number of active ingredient(s):
1
Schedule(s):
Prescription
American Hospital Formulary Service (AHFS): See footnote 3
56:22.20
Anatomical Therapeutic Chemical (ATC): See footnote 4
A04AA01 ONDANSETRON
Active ingredient group (AIG) number:See footnote5
0131120004
| Active ingredient(s) See footnote8 | Strength |
|---|---|
| ONDANSETRON (ONDANSETRON HYDROCHLORIDE DIHYDRATE) | 2.00 MG / ML |