Approval · Notice of Compliance 18325 · 2016
SELEXID: Notice of Compliance 18325
Issued July 29, 2016
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
- 18325
- Date
- July 29, 2016
- Company
- Leo Pharma IncToronto, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- To propose new 400 mg strength tablet, manufacturing changes and an updated product monograph
Products in this notice
Medicinal ingredients
- PIVMECILLINAM HCL 200 MG per TAB
- PIVMECILLINAM HCL 400 MG per TAB