Approval · Notice of Compliance 17841 · 2016
APO-METHYLPHENIDATE ER: Notice of Compliance 17841
Issued March 7, 2016
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
- 17841
- Date
- March 7, 2016
- 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, change in the drug product specifications for the 54 mg
- Canadian reference product
- CONCERTA (Janssen-Ortho Inc.)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| APO-METHYLPHENIDATE ER | 02452731 | Marketed |
| APO-METHYLPHENIDATE ER | 02452758 | Marketed |
| APO-METHYLPHENIDATE ER | 02452766 | Marketed |
| APO-METHYLPHENIDATE ER | Not yet assigned | — |
Medicinal ingredients
- METHYLPHENIDATE HYDROCHLORIDE 18 MG per TAB
- METHYLPHENIDATE HYDROCHLORIDE 27 MG per TAB
- METHYLPHENIDATE HYDROCHLORIDE 36 MG per TAB
- METHYLPHENIDATE HYDROCHLORIDE 54 MG per TAB