Approval · Notice of Compliance 8725 · 2007
DOM-AZITHROMYCIN: Notice of Compliance 8725
Issued April 18, 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
- 8725
- Date
- April 18, 2007
- Company
- Dominion PharmacalMontreal, Quebec, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to an Abbreviated New Drug Submission (SANDS), supplement
- Submission class
- Admin
- Reason
- New dosage form
- Therapeutic class
- Antibiotic
- Canadian reference product
- ZITHROMAX (Pfizer Canada Ulc)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| DOM-AZITHROMYCIN | 02282429 | Cancelled Pre Market |
| DOM-AZITHROMYCIN | 02282437 | Cancelled Pre Market |
Medicinal ingredients
- AZITHROMYCIN MONOHYDRATE HEMIETHANOLATE 100 MG per 5ML
- AZITHROMYCIN MONOHYDRATE HEMIETHANOLATE 200 MG per 5ML