Approval · Notice of Compliance 10831 · 2009
AZITHROMYCIN: Notice of Compliance 10831
Issued December 4, 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
- 10831
- Date
- December 4, 2009
- Company
- Sanis Health Inc.Brampton, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Abbreviated New Drug Submission (ANDS)
- Submission class
- Admin
- Reason
- Manufacturer name change
- Therapeutic class
- Antibiotic
- Canadian reference product
- ZITHROMAX (Pfizer Canada Ulc)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| AZITHROMYCIN | 02330881 | Marketed |
| AZITHROMYCIN | 02330911 | Cancelled Post Market |
Medicinal ingredients
- AZITHROMYCIN MONOHYDRATE 250 MG per TAB
- AZITHROMYCIN MONOHYDRATE 600 MG per TAB