Approval · Notice of Compliance 9380 · 2008
TRAMACET: Notice of Compliance 9380
Issued February 14, 2008
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
- 9380
- Date
- February 14, 2008
- Company
- Janssen-Ortho Inc.
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New indication: for the management of moderate to moderately severe pain in adults
- Therapeutic class
- Centrally acting analgesic
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| TRAMACET | Not yet assigned | — |
Medicinal ingredients
- TRAMADOL HCL 37.5 MG per TAB
- ACETAMINOPHEN 325 MG per TAB