ApprovalTrail

Approval · Notice of Compliance 29797 · 2022

ZOPICLONE TABLETS: Notice of Compliance 29797

Issued December 28, 2022

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
29797
Date
December 28, 2022
Company
Nora Pharma Inc.Varennes, Quebec, Canada
Product type
Prescription Pharmaceutical
Submission
Supplement to an Abbreviated New Drug Submission (SANDS), supplement
Submission class
Admin
Reason
Administrative: Labelling Update (to Match Licensor)
Canadian reference product
IMOVANE (Sanofi-Aventis Canada Inc.)

Products in this notice

BrandDINStatus today
ZOPICLONE TABLETSNot yet assigned—

Medicinal ingredients