Approval · Notice of Compliance 7913 · 2006
GEN-AZITHROMYCIN: Notice of Compliance 7913
Issued May 1, 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
- 7913
- Date
- May 1, 2006
- Company
- Genpharm Inc.Etobicoke, Ontario, 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 |
|---|---|---|
| GEN-AZITHROMYCIN | 02278359 | Cancelled Post Market |
| GEN-AZITHROMYCIN | 02278367 | — |
Medicinal ingredients
- AZITHROMYCIN MONOHYDRATE HEMIETHANOLATE 250 MG per TAB
- AZITHROMYCIN MONOHYDRATE HEMIETHANOLATE 600 MG per TAB