Approval · Notice of Compliance 18584 · 2016
ACT AZITHROMYCIN: Notice of Compliance 18584
Issued October 18, 2016
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
- 18584
- Date
- October 18, 2016
- Company
- Actavis Pharma CompanyToronto, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to an Abbreviated New Drug Submission (SANDS), supplement
- Submission class
- Other
- Reason
- Alternate manufacturing site for the active pharmaceutical ingredient
- Canadian reference product
- ZITHROMAX (Pfizer Canada Ulc)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| ACT AZITHROMYCIN | Not yet assigned | — |
Medicinal ingredients
- AZITHROMYCIN MONOHYDRATE 250 MG per TAB
- AZITHROMYCIN MONOHYDRATE 600 MG per TAB