Approval · Notice of Compliance 34652 · 2025
APO-DEXTROAMPHETAMINE SR: Notice of Compliance 34652
Issued January 3, 2025
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
- 34652
- Date
- January 3, 2025
- 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 (to align with CRP approved PM) / New package insert
- Canadian reference product
- DEXEDRINE AND DEXEDRINE SPANSULE (Paladin Labs Inc)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| APO-DEXTROAMPHETAMINE SR | Not yet assigned | — |
Medicinal ingredients
- DEXTROAMPHETAMINE SULFATE 10 MG per CAP
- DEXTROAMPHETAMINE SULFATE 15 MG per CAP