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:

2017-07-14

Original market date: See footnote 1

1992-12-31

Lot number: See footnote 2

XFDF

Expiry date: See footnote 2

2019-12-31

Product name:

HYCODAN SYRUP

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:

01916580

Product Monograph/Veterinary Labelling:

Date: 2017-04-12 Product monograph/Veterinary Labelling (PDF version ~ 175K)

Company:

BRISTOL-MYERS SQUIBB CANADA
2344 Boul. Alfred-Nobel, Suite 300
St-Laurent
Quebec
Canada H4S 0A4

Class:

Human

Dosage form(s):

Syrup

Route(s) of administration:

Oral

Number of active ingredient(s):

1

Schedule(s):

Narcotic (CDSA I)

 

American Hospital Formulary Service (AHFS): See footnote 3

48:08.00 

Anatomical Therapeutic Chemical (ATC): See footnote 4

R05DA03 HYDROCODONE

Active ingredient group (AIG) number:See footnote5

0107555001

List of active ingredient(s)
Active ingredient(s) See footnote8 Strength
HYDROCODONE BITARTRATE 5 MG / 5 ML
Version 4.0.3

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