Approval · Notice of Compliance 25634 · 2021
ETODOLAC: Notice of Compliance 25634
Issued April 9, 2021
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
- 25634
- Date
- April 9, 2021
- Company
- Apotex Inc.Toronto, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Abbreviated New Drug Submission (ANDS)
- Submission class
- Labelling Only
- Reason
- Change in product ownership. din transfer. change brand name. update product monograph. update labelling materials
- Canadian reference product
- ULTRADOL (Procter & Gamble Pharmaceuticals Canada, Inc)