ApprovalTrail

Approval · Notice of Compliance 22499 · 2019

SANDOZ FENTANYL PATCH: Notice of Compliance 22499

Issued August 2, 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
22499
Date
August 2, 2019
Company
Sandoz Canada Inc.Saint-Hubert, Quebec, Canada
Product type
Prescription Pharmaceutical
Submission
Supplement to an Abbreviated New Drug Submission (SANDS), supplement
Submission class
Labelling Only
Reason
Revision to package insert and inner and outer labels
Canadian reference product
DURAGESIC (Janssen-Ortho Inc.)

Products in this notice

BrandDINStatus today
SANDOZ FENTANYL PATCHNot yet assigned—

Medicinal ingredients