Approval · Notice of Compliance 13891 · 2012
APO-OXYCODONE CR: Notice of Compliance 13891
Issued November 26, 2012
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
- 13891
- Date
- November 26, 2012
- Company
- Apotex Inc.Toronto, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to an Abbreviated New Drug Submission (SANDS), supplement
- Submission class
- Other
- Reason
- New Strengths
- Therapeutic class
- Opioid analgesic
- Canadian reference product
- OXYCONTIN (Purdue Pharma)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| APO-OXYCODONE CR | 02394766 | Marketed |
| APO-OXYCODONE CR | 02394774 | Marketed |
| APO-OXYCODONE CR | 02394782 | Marketed |
Medicinal ingredients
- OXYCODONE HYDROCHLORIDE 15 MG per TAB
- OXYCODONE HYDROCHLORIDE 30 MG per TAB
- OXYCODONE HYDROCHLORIDE 60 MG per TAB