Approval · Notice of Compliance 27860 · 2022
DURELA: Notice of Compliance 27860
Issued March 31, 2022
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
- 27860
- Date
- March 31, 2022
- Company
- Cipher Pharmaceuticals Inc.Mississauga, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Safety updates to the PM, PM conversion to 2020 PM format and updates to the labels as per the Advisement Letter.
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| DURELA | Not yet assigned | — |
Medicinal ingredients
- TRAMADOL HCL 100 MG per CAP
- TRAMADOL HCL 200 MG per CAP
- TRAMADOL HCL 300 MG per CAP