Approval · Notice of Compliance 21842 · 2019
ENABLEX: Notice of Compliance 21842
Issued February 11, 2019
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
- 21842
- Date
- February 11, 2019
- Company
- Searchlight Pharma Inc.Montreal, Quebec, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- New Drug Submission (NDS)
- Submission class
- Labelling Only
- Reason
- A change in product ownership from mjerus labs to searchlight pharma inc., and to add a pvc-pvdc with aluminum foil blister pack of 7 tablets for the 7.5 mg tablet
Products in this notice
Medicinal ingredients
- DARIFENACIN HYDROBROMIDE 7.5 MG per TAB
- DARIFENACIN HYDROBROMIDE 15 MG per TAB