Approval · Notice of Compliance 814 · 2002
URSO: Notice of Compliance 814
Issued June 19, 2002
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
- 814
- Date
- June 19, 2002
- Company
- Axcan Pharma Inc.Mont St-Hilaire, Quebec, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New strength: 500mg
- Therapeutic class
- Cholestatic liver diseases
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| URSO | 02245894 | Cancelled Post Market |
Medicinal ingredients
- URSODIOL 500 MG per TAB