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:
2013-06-01
Original market date: See footnote 1
1952-12-31
Product name:
DARAPRIM
DIN:
00004774
Product Monograph/Veterinary Labelling:
Date:
2012-12-03
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
AMEDRA PHARMACEUTICALS LLC
2 Walnut Grove Drive, Suite 190
Horsham
Pennsylvania
United States
19044
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
08:30.08
Anatomical Therapeutic Chemical (ATC): See footnote 4
P01BD01 PYRIMETHAMINE
Active ingredient group (AIG) number:See footnote5
0107634001
| Active ingredient(s) | Strength |
|---|---|
| PYRIMETHAMINE | 25 MG |