ApprovalTrail

Approval · Notice of Compliance 35706 · 2025

APO-CLARITHROMYCIN: Notice of Compliance 35706

Issued July 22, 2025

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
35706
Date
July 22, 2025
Company
Apotex Inc.Toronto, Ontario, Canada
Product type
Prescription Pharmaceutical
Submission
Supplement to an Abbreviated New Drug Submission (SANDS), supplement
Submission class
Other
Reason
Update to The Product Monograph. Update to the Package Insert
Canadian reference product
BIAXIN. BIAXIN BD (Abbott Laboratories Co.)

Products in this notice

BrandDINStatus today
APO-CLARITHROMYCINNot yet assigned—
APO-CLARITHROMYCIN XLNot yet assigned—

Medicinal ingredients