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:

2004-01-29

Original market date: See footnote 1

2004-01-29

Product name:

4% ASTRACAINE DENTAL WITH EPINEPHRINE FORTE 1:100,000 (0.01MG/ML)

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DIN:

02248488

Product Monograph/Veterinary Labelling:

Date: 2018-06-14 Product monograph/Veterinary Labelling (PDF version ~ 175K)

Company:

DENTSPLY CANADA LIMITED
1 525 Rowntree Dairy Road
Woodbridge
Ontario
Canada L4L 7K6

Class:

Human

Dosage form(s):

Solution

Route(s) of administration:

Block/Infiltration

Number of active ingredient(s):

2

Schedule(s):

Ethical

 

American Hospital Formulary Service (AHFS): See footnote 3

72:00.00 

Anatomical Therapeutic Chemical (ATC): See footnote 4

N01BB58 ARTICAINE, COMBINATIONS

Active ingredient group (AIG) number:See footnote5

0226661001

List of active ingredient(s)
Active ingredient(s) Strength
ARTICAINE HYDROCHLORIDE 40 MG / ML
EPINEPHRINE (EPINEPHRINE BITARTRATE) 0.01 MG / ML
Version 4.0.2
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