Approval · Notice of Compliance 10491 · 2009
AMLODIPINE: Notice of Compliance 10491
Issued August 11, 2009
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
- 10491
- Date
- August 11, 2009
- Company
- Mylan Pharmaceuticals UlcEtobicoke, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Abbreviated New Drug Submission (ANDS)
- Submission class
- Admin
- Reason
- New manufacturer and product name
- Therapeutic class
- Antihypertensive / Antianginal agent
- Canadian reference product
- NORVASC (Pfizer Canada Ulc)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| AMLODIPINE | 02331284 | Marketed |
| AMLODIPINE | 02331292 | Marketed |
Medicinal ingredients
- AMLODIPINE BESYLATE 5 MG per TAB
- AMLODIPINE BESYLATE 10 MG per TAB