Approval · Notice of Compliance 34050 · 2024
APO-OXYCODONE CR: Notice of Compliance 34050
Issued September 19, 2024
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
- 34050
- Date
- September 19, 2024
- 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 Product Monograph
- Canadian reference product
- OXYCONTIN (Purdue Pharma)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| APO-OXYCODONE CR | Not yet assigned | — |
Medicinal ingredients
- OXYCODONE HYDROCHLORIDE 5 MG per TAB
- OXYCODONE HYDROCHLORIDE 10 MG per TAB
- OXYCODONE HYDROCHLORIDE 15 MG per TAB
- OXYCODONE HYDROCHLORIDE 20 MG per TAB
- OXYCODONE HYDROCHLORIDE 30 MG per TAB
- OXYCODONE HYDROCHLORIDE 40 MG per TAB
- OXYCODONE HYDROCHLORIDE 60 MG per TAB
- OXYCODONE HYDROCHLORIDE 80 MG per TAB