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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:

2009-09-24

Original market date: See footnote 1

1992-12-31

Product name:

DEXEDRINE TABLETS (5MG)

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:

01924516

Product Monograph/Veterinary Labelling:

Date: 2020-10-29 Product monograph/Veterinary Labelling (PDF version ~ 175K)

Company: 

PALADIN LABS INC.
100 Blvd Alexis-Nihon, Suite 600
Saint-Laurent
Quebec
Canada  H4M 2P2

Class: 

Human

Dosage form(s):

Tablet

Route(s) of administration:

Oral

Number of active ingredient(s):

1

Schedule(s):

Schedule G (CDSA I)  

Biosimilar Biologic Drug:

No

American Hospital Formulary Service (AHFS): See footnote 3

28:20.04   AMPHETAMINES

Anatomical Therapeutic Chemical (ATC): See footnote 4

N06BA02  DEXAMFETAMINE

Active ingredient group (AIG) number:See footnote 5

0105933002

List of active ingredient(s)
Active ingredient(s) Strength
DEXTROAMPHETAMINE SULFATE 5 MG

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