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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:

2017-10-31

Original market date: See footnote 1

2017-10-31

Product name:

TARO-TESTOSTERONE GEL

Description:

2.5G GEL PER PACK

Help on accessing alternative formats, such as Portable Document Format (PDF), Microsoft Word and PowerPoint (PPT) files, can be obtained in the alternate format help section .

DIN:

02463792

Product Monograph/Veterinary Labelling:

Date: 2020-10-19 Product monograph/Veterinary Labelling (PDF version ~ 175K)

Company: 

TARO PHARMACEUTICALS INC
130 East Drive
Brampton
Ontario
Canada  L6T 1C1

Class: 

Human

Dosage form(s):

Gel

Route(s) of administration:

Transdermal

Number of active ingredient(s):

1

Schedule(s):

Schedule G (CDSA IV)  

Biosimilar Biologic Drug:

No

American Hospital Formulary Service (AHFS): See footnote 3

68:08.00   ANDROGENS

Anatomical Therapeutic Chemical (ATC): See footnote 4

G03BA03  TESTOSTERONE

Active ingredient group (AIG) number:See footnote 5

0106405004

List of active ingredient(s)
Active ingredient(s) Strength
TESTOSTERONE 1 %

Application information

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