Approval · Notice of Compliance 22207 · 2019
ZITHROMAX: Notice of Compliance 22207
Issued May 28, 2019
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
- 22207
- Date
- May 28, 2019
- Company
- Pfizer Canada UlcKirkland, Quebec, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- The addition of an alternate product manufacturing and testing site, batch size, markings, scoring configuration, manufacturing process and controls. Also, revisions to package inserts to comply with PLL regulations
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| ZITHROMAX | Not yet assigned | — |
Medicinal ingredients
- AZITHROMYCIN 250 MG per TAB
- AZITHROMYCIN 600 MG per TAB