Approval · Notice of Compliance 10197 · 2009
OXYCODONE: Notice of Compliance 10197
Issued May 7, 2009
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
- 10197
- Date
- May 7, 2009
- Company
- Pro Doc LimiteeLaval, Quebec, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Abbreviated New Drug Submission (ANDS)
- Submission class
- Admin
- Reason
- New manufacturer and product name
- Therapeutic class
- Opioid analgesic
- Canadian reference product
- OXY-IR (Purdue Pharma)
Products in this notice
Medicinal ingredients
- OXYCODONE HYDROCHLORIDE 5 MG per TAB
- OXYCODONE HYDROCHLORIDE 10 MG per TAB
- OXYCODONE HYDROCHLORIDE 20 MG per TAB