ApprovalTrail

Approval · Notice of Compliance 31848 · 2023

DUOKOPT: Notice of Compliance 31848

Issued October 12, 2023

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
31848
Date
October 12, 2023
Company
Laboratoires ThéaClermont-Ferrand, Cedex 2, France
Product type
Prescription Pharmaceutical
Submission
Supplement to an Abbreviated New Drug Submission (SANDS), supplement
Submission class
Other
Reason
Replacement or addition of a drug product manufacturer / manufacturing site, involving production
Canadian reference product
COSOPT (Purdue Pharma)

Products in this notice

BrandDINStatus today
DUOKOPTNot yet assigned—

Medicinal ingredients