Approval · Notice of Compliance 200 · 2002
ZITHROMAX: Notice of Compliance 200
Issued August 20, 2002
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
- 200
- Date
- August 20, 2002
- Company
- Pfizer Canada UlcKirkland, Quebec, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Accelerated dosing in pediatric patients for acute otitis media: 30 mg/kg single dose for 1 day, 10 mg/kg once daily for 3 days, product monograph revisions
- Therapeutic class
- Antibiotic
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| ZITHROMAX | Not yet assigned | — |
Medicinal ingredients
- AZITHROMYCIN 100 MG per 5ML
- AZITHROMYCIN 200 MG per 5ML
- AZITHROMYCIN 500 MG per VIAL