Approval · Notice of Compliance 30822 · 2023
DIVALPROEX: Notice of Compliance 30822
Issued May 25, 2023
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
- 30822
- Date
- May 25, 2023
- 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 drug substance manufacturer. Change in the drug product manufacturing process. Control of drug product: change in the specification for the drug product
- Canadian reference product
- EPIVAL (Abbott Laboratories Co.)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| DIVALPROEX | Not yet assigned | — |
Medicinal ingredients
- DIVALPROEX SODIUM 125 MG per TAB
- DIVALPROEX SODIUM 250 MG per TAB
- DIVALPROEX SODIUM 500 MG per TAB