Approval · Notice of Compliance 35010 · 2025
ZERBAXA: Notice of Compliance 35010
Issued March 14, 2025
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
- 35010
- Date
- March 14, 2025
- Company
- Merck Canada IncKirkland, Quebec, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Addition of a manufacturing site and/or manufacturer involving production of the drug substance intermediate. Change in the manufacturing process for the intermediate.
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| ZERBAXA | Not yet assigned | — |
Medicinal ingredients
- TAZOBACTAM SODIUM 500 MG per VIAL
- CEFTOLOZANE SULFATE 1,000 MG per VIAL