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:

Approved

Current status date:

2023-09-21

Product name:

QUILLIVANT ER CHEWABLE TABLETS

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:

02541602

Product Monograph/Veterinary Labelling:

Date: 2023-09-20 Product monograph/Veterinary Labelling (PDF version ~ 175K)

Company:

KYE PHARMACEUTICALS INC.
2233 Argentia Road, East Tower, Suite 302 & 302a
Mississauga
Ontario
Canada L5N 2X7

Class:

Human

Dosage form(s):

Tablet (Chewable, Extended-Release)

Route(s) of administration:

Oral

Number of active ingredient(s):

1

Schedule(s):

Schedule G (CDSA III)

 

American Hospital Formulary Service (AHFS): See footnote 3

28:20.32 

Anatomical Therapeutic Chemical (ATC): See footnote 4

N06BA04 METHYLPHENIDATE

Active ingredient group (AIG) number:See footnote5

0107548002

List of active ingredient(s)
Active ingredient(s) Strength
METHYLPHENIDATE HYDROCHLORIDE 20 MG
Version 4.0.2
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