Approval · Notice of Compliance 21867 · 2019
APO-AMITRIPTYLINE: Notice of Compliance 21867
Issued February 15, 2019
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
- 21867
- Date
- February 15, 2019
- Company
- Apotex Inc.Toronto, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Labelling Only
- Reason
- Product monograph update to match reference product elavil and label design updates
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| APO-AMITRIPTYLINE | Not yet assigned | — |
Medicinal ingredients
- AMITRIPTYLINE HCL 10 MG per TAB
- AMITRIPTYLINE HCL 25 MG per TAB
- AMITRIPTYLINE HCL 50 MG per TAB
- AMITRIPTYLINE HCL 75 MG per TAB