Approval · Notice of Compliance 15873 · 2014
TRAMADOL/ACET: Notice of Compliance 15873
Issued July 24, 2014
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
- 15873
- Date
- July 24, 2014
- Company
- Sanis Health Inc.Brampton, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Abbreviated New Drug Submission (ANDS)
- Submission class
- Admin
- Reason
- Licensing agreement between two companies
- Therapeutic class
- Centrally acting analgesic
- Canadian reference product
- TRAMACET (Janssen-Ortho Inc.)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| TRAMADOL/ACET | 02426803 | Cancelled Post Market |
Medicinal ingredients
- ACETAMINOPHEN 325 MG per TAB
- TRAMADOL HCL 37.5 MG per TAB