Approval · Notice of Compliance 30985 · 2023
APO-NORTRIPTYLINE: Notice of Compliance 30985
Issued June 7, 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
- 30985
- Date
- June 7, 2023
- Company
- Apotex Inc.Toronto, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to an Abbreviated New Drug Submission (SANDS), supplement
- Submission class
- Admin
- Reason
- Administrative: Labelling Update (to match Licensor)
- Canadian reference product
- AVENTYL (Eli Lilly Canada Inc)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| APO-NORTRIPTYLINE | Not yet assigned | — |
Medicinal ingredients
- NORTRIPTYLINE HCL 10 MG per CAP
- NORTRIPTYLINE HCL 25 MG per CAP