Approval · Notice of Compliance 18347 · 2016
AMLODIPINE: Notice of Compliance 18347
Issued August 8, 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
- 18347
- Date
- August 8, 2016
- Company
- Sivem Pharmaceuticals UlcSaint-Laurent, Quebec, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Abbreviated New Drug Submission (ANDS)
- Submission class
- Admin
- Reason
- Licensing agreement between two companies
- Canadian reference product
- NORVASC (Pfizer Canada Ulc)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| AMLODIPINE | 02385783 | Marketed |
| AMLODIPINE | 02385791 | Marketed |
| AMLODIPINE | 02385805 | Marketed |
Medicinal ingredients
- AMLODIPINE BESYLATE 2.5 MG per TAB
- AMLODIPINE BESYLATE 5 MG per TAB
- AMLODIPINE BESYLATE 10 MG per TAB