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:
2019-03-18
Original market date: See footnote 1
1990-12-30
Product name:
NIZORAL
DIN:
02182920
Product Monograph/Veterinary Labelling:
Date:
2019-03-05
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
KRAMER LABORATORIES, INC
440 Route 22 East, Suite 210
Bridgewater
New Jersey
United States
08807
Class:
Human
Dosage form(s):
Shampoo
Route(s) of administration:
Topical
Number of active ingredient(s):
1
Schedule(s):
OTC
American Hospital Formulary Service (AHFS): See footnote 3
84:04.08.08
Anatomical Therapeutic Chemical (ATC): See footnote 4
D01AC08 KETOCONAZOLE
Active ingredient group (AIG) number:See footnote5
0116793002
| Active ingredient(s) | Strength |
|---|---|
| KETOCONAZOLE | 2 % |