Approval · Notice of Compliance 15663 · 2014
CLAFORAN: Notice of Compliance 15663
Issued May 27, 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
- 15663
- Date
- May 27, 2014
- Company
- Sanofi-Aventis Canada Inc.Toronto, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Addition of an alternate drug substance manufacturing, testing and release site and drug product manufacturing site changes. update to the product monograph to reflect the discontiuation of the 500 mg tablet
- Therapeutic class
- Antibiotic
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| CLAFORAN | Not yet assigned | — |
Medicinal ingredients
- CEFOTAXIME SODIUM 1 G per VIAL
- CEFOTAXIME SODIUM 2 G per VIAL