Approval · Notice of Compliance 13889 · 2012
APO-OXYCODONE CR: Notice of Compliance 13889
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
- 13889
- 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
- Additional Strengths
- Therapeutic class
- Opioid analgesic
- Canadian reference product
- OXYCONTIN (Purdue Pharma)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| APO-OXYCODONE CR | 02366746 | Marketed |
| APO-OXYCODONE CR | 02366754 | Marketed |
| APO-OXYCODONE CR | 02366762 | Marketed |
| APO-OXYCODONE CR | 02366789 | Marketed |
Medicinal ingredients
- OXYCODONE HYDROCHLORIDE 5 MG per TAB
- OXYCODONE HYDROCHLORIDE 10 MG per TAB
- OXYCODONE HYDROCHLORIDE 20 MG per TAB
- OXYCODONE HYDROCHLORIDE 80 MG per TAB