Approval · Notice of Compliance 8677 · 2007
PHL-AZITHROMYCIN: Notice of Compliance 8677
Issued March 27, 2007
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
- 8677
- Date
- March 27, 2007
- Company
- Pharmel Inc.Montreal, Quebec, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Abbreviated New Drug Submission (ANDS)
- Submission class
- Admin
- Reason
- New manufacturer and product name
- Therapeutic class
- Antibiotic
- Canadian reference product
- ZITHROMAX (Pfizer Canada Ulc)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| PHL-AZITHROMYCIN | 02278588 | Cancelled Post Market |
| PHL-AZITHROMYCIN | 02278596 | Cancelled Pre Market |
Medicinal ingredients
- AZITHROMYCIN MONOHYDRATE HEMIETHANOLATE 250 MG per TAB
- AZITHROMYCIN MONOHYDRATE HEMIETHANOLATE 600 MG per TAB