Approval · Notice of Compliance 16134 · 2014
ACT AZITHROMYCIN: Notice of Compliance 16134
Issued September 26, 2014
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
- 16134
- Date
- September 26, 2014
- Company
- Actavis Pharma CompanyToronto, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Abbreviated New Drug Submission (ANDS)
- Submission class
- Admin
- Reason
- Manufacturer and product name change
- Therapeutic class
- Antibiotic
- Canadian reference product
- ZITHROMAX (Pfizer Canada Ulc)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| ACT AZITHROMYCIN | 02255340 | Cancelled Post Market |
| ACT AZITHROMYCIN | 02256088 | Cancelled Post Market |
Medicinal ingredients
- AZITHROMYCIN MONOHYDRATE 250 MG per TAB
- AZITHROMYCIN MONOHYDRATE 600 MG per TAB