Approval · Notice of Compliance 35636 · 2025
RAN-CLARITHROMYCIN: Notice of Compliance 35636
Issued July 8, 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
- 35636
- Date
- July 8, 2025
- Company
- Sun Pharma Canada Inc.Brampton, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to an Abbreviated New Drug Submission (SANDS), supplement
- Submission class
- Other
- Reason
- Update to Product Monograph (to align with CRP approved PM). Update to package labels
- Canadian reference product
- BIAXIN BID / BIAXIN XL / BIAXIN (Abbott Laboratories Co.)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| RAN-CLARITHROMYCIN | Not yet assigned | — |
| TARO-CLARITHROMYCIN | Not yet assigned | — |
| TARO-CLARITHROMYCIN XL | Not yet assigned | — |
Medicinal ingredients
- CLARITHROMYCIN 125 MG per 5ML
- CLARITHROMYCIN 250 MG per 5ML
- CLARITHROMYCIN 250 MG per TAB
- CLARITHROMYCIN 500 MG per TAB