ApprovalTrail

Approval · Notice of Compliance 29355 · 2022

COZAAR: Notice of Compliance 29355

Issued November 1, 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
29355
Date
November 1, 2022
Company
Organon Canada Inc.Kirkland, Quebec, Canada
Product type
Prescription Pharmaceutical
Submission
Supplement to a New Drug Submission (SNDS), supplement
Submission class
Other
Reason
Plain Language Labelling (PLL) review of the labels for the 50 and 100 mg strengths due to a transfer in the drug product packaging and labelling site

Products in this notice

BrandDINStatus today
COZAARNot yet assigned—

Medicinal ingredients