Approval · Notice of Compliance 8199 · 2006
PHL-AZITHROMYCIN: Notice of Compliance 8199
Issued August 10, 2006
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
- 8199
- Date
- August 10, 2006
- Company
- Pharmel Inc.Montreal, 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 |
|---|---|---|
| PHL-AZITHROMYCIN | 02282380 | Cancelled Post Market |
| PHL-AZITHROMYCIN | 02282410 | Cancelled Post Market |
Medicinal ingredients
- AZITHROMYCIN MONOHYDRATE HEMIETHANOLATE 100 MG per 5ML
- AZITHROMYCIN MONOHYDRATE HEMIETHANOLATE 200 MG per 5ML