Approval · Notice of Compliance 3153 · 1998
URSO: Notice of Compliance 3153
Issued November 1, 1998
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
- 3153
- Date
- November 1, 1998
- Company
- Axcan Pharma Inc.Mont St-Hilaire, Quebec, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Priority
- Reason
- Provides for a new dosage form, change in product name from ursofalk to urso
- Therapeutic class
- Litholytic agent, cholestatic liver diseases
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| URSO | 02238984 | Cancelled Post Market |
Medicinal ingredients
- URSODIOL 250 MG per TAB