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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:

2018-07-30

Original market date: See footnote 1

1993-12-31

Product name:

DANTRIUM INTRAVENOUS

Description:

PWS 20MG/VIAL

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:

01997572

Product Monograph/Veterinary Labelling:

Date: 2018-04-23 Product monograph/Veterinary Labelling (PDF version ~ 175K)

Company: 

ENDO PAR INNOVATION COMPANY, LLC
6 Ram Ridge Road
Chestnut Ridge
New York
United States  10977

Class: 

Human

Dosage form(s):

Powder For Solution

Route(s) of administration:

Intravenous

Number of active ingredient(s):

1

Schedule(s):

Prescription  

Biosimilar Biologic Drug:

No

American Hospital Formulary Service (AHFS): See footnote 3

12:20.08   DIRECT-ACTING SKELETAL MUSCLE RELAXANTS

Anatomical Therapeutic Chemical (ATC): See footnote 4

M03CA01  DANTROLENE

Active ingredient group (AIG) number:See footnote 5

0109855003

List of active ingredient(s)
Active ingredient(s) Strength
DANTROLENE SODIUM 20 MG / VIAL

Application information

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