Approval · Notice of Compliance 34335 · 2024
DEXEDRINE: Notice of Compliance 34335
Issued November 6, 2024
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
- 34335
- Date
- November 6, 2024
- Company
- Endo Operations Ltd.Ballsbridge, Dublin, Ireland
- Product type
- Prescription Pharmaceutical
- Submission
- New Drug Submission (NDS)
- Submission class
- Labelling Only
- Reason
- Change in product ownership
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| DEXEDRINE | 01924516 | Marketed |
| DEXEDRINE SPANSULE | 01924559 | Marketed |
| DEXEDRINE SPANSULE | 01924567 | Marketed |
Medicinal ingredients
- DEXTROAMPHETAMINE SULFATE 5 MG per TAB
- DEXTROAMPHETAMINE SULFATE 10 MG per CAP
- DEXTROAMPHETAMINE SULFATE 15 MG per CAP