Approval · Notice of Compliance 21232 · 2018
CLAVULIN: Notice of Compliance 21232
Issued August 17, 2018
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
- 21232
- Date
- August 17, 2018
- Company
- Glaxosmithkline IncMississauga, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- To align the common name across the Clavulin labels to include updates to the Common Name in relation to the Pharmaceutical Standard being claimed and streamlining of text on inner and outer labels to maximize font size and readability
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| CLAVULIN | Not yet assigned | — |
Medicinal ingredients
- AMOXICILLIN 500 MG per TAB
- CLAVULANIC ACID 125 MG per TAB
- AMOXICILLIN 875 MG per TAB
- AMOXICILLIN 125 MG per 5ML
- CLAVULANIC ACID 31.25 MG per 5ML
- AMOXICILLIN 200 MG per 5ML
- CLAVULANIC ACID 28.5 MG per 5ML
- AMOXICILLIN 250 MG per 5ML
- CLAVULANIC ACID 62.5 MG per 5ML
- AMOXICILLIN 400 MG per 5ML
- CLAVULANIC ACID 57 MG per 5ML