Approval · Notice of Compliance 28308 · 2022
RAN-CLARITHROMYCIN: Notice of Compliance 28308
Issued June 2, 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
- 28308
- Date
- June 2, 2022
- Company
- Sun Pharma Canada Inc.Brampton, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Abbreviated New Drug Submission (ANDS)
- Submission class
- Labelling Only
- Reason
- Administrative: Manufacturer and Product Name Change/Administrative: Manufacturer Name Change/Safety updates to the product monograph/To convert the product monograph to 2020 format
- Canadian reference product
- BIAXIN BID, BIAXIN AND BIAXIN XL (Abbott Laboratories Co.)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| RAN-CLARITHROMYCIN | 02387115 | Approved |
| RAN-CLARITHROMYCIN | 02387107 | Approved |
| TARO-CLARITHROMYCIN | 02361426 | Marketed |
| TARO-CLARITHROMYCIN | 02361434 | Marketed |
| TARO-CLARITHROMYCIN XL | 02410036 | Approved |
Medicinal ingredients
- CLARITHROMYCIN 125 MG per 5ML
- CLARITHROMYCIN 250 MG per 5ML
- CLARITHROMYCIN 250 MG per TAB
- CLARITHROMYCIN 500 MG per TAB