ApprovalTrail

Approval · Notice of Compliance 22284 · 2019

FOSAPREPITANT: Notice of Compliance 22284

Issued June 14, 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
22284
Date
June 14, 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 the product monograph and package insert
Canadian reference product
EMEND IV (Merck Canada Inc)

Products in this notice

BrandDINStatus today
FOSAPREPITANTNot yet assigned—

Medicinal ingredients