ApprovalTrail

Approval · Notice of Compliance 22697 · 2019

APO-MODAFINIL: Notice of Compliance 22697

Issued September 26, 2019

A Notice of Compliance is Health Canada’s approval of a drug submission: a new drug, a new use or form, or a change to an approved one. The product itself is in the Drug Product Database, with its current status.

Notice number
22697
Date
September 26, 2019
Company
Apotex Inc.Toronto, Ontario, Canada
Product type
Prescription Pharmaceutical
Submission
Supplement to an Abbreviated New Drug Submission (SANDS), supplement
Submission class
Labelling Only
Reason
Update to product monograph
Canadian reference product
ALERTREC (Shire Biochem Inc.)

Products in this notice

BrandDINStatus today
APO-MODAFINILNot yet assigned—

Medicinal ingredients