ApprovalTrail

Approval · Notice of Compliance 36622 · 2025

PRO-CLARITHROMYCIN: Notice of Compliance 36622

Issued December 23, 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
36622
Date
December 23, 2025
Company
Pro Doc LimiteeLaval, Quebec, Canada
Product type
Prescription Pharmaceutical
Submission
Supplement to an Abbreviated New Drug Submission (SANDS), supplement
Submission class
Admin
Reason
Administrative: Change in product name. Administrative: Update to labelling (to match Licensor)
Canadian reference product
BIAXIN BID (Abbott Laboratories Co.)

Products in this notice

BrandDINStatus today
PRO-CLARITHROMYCIN02324482Marketed
PRO-CLARITHROMYCIN02324490Marketed

Medicinal ingredients