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:

2013-06-04

Original market date: See footnote 1

2013-06-04

Product name:

MYLAN-NITRO PATCH 0.4

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:

02407450

Product Monograph/Veterinary Labelling:

Date: 2019-06-19 Product monograph/Veterinary Labelling (PDF version ~ 175K)

Company:

MYLAN PHARMACEUTICALS ULC
85 Advance Road
Etobicoke
Ontario
Canada M8Z 2S6

Class:

Human

Dosage form(s):

Patch (Extended Release)

Route(s) of administration:

Transdermal

Number of active ingredient(s):

1

Schedule(s):

Ethical

 

American Hospital Formulary Service (AHFS): See footnote 3

24:12.08 

Anatomical Therapeutic Chemical (ATC): See footnote 4

C01DA02 GLYCERYL TRINITRATE

Active ingredient group (AIG) number:See footnote5

0103615009

List of active ingredient(s)
Active ingredient(s) Strength
NITROGLYCERIN 0.4 MG / HOUR
Version 4.0.2
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