Approval · Notice of Compliance 22522 · 2019
CLAVULIN: Notice of Compliance 22522
Issued August 9, 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
- 22522
- Date
- August 9, 2019
- Company
- Glaxosmithkline IncMississauga, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Labelling Only
- Reason
- To update the Package Insert and package labels for CLAVULIN powder for suspension due to a planned manufacturing site change.
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| CLAVULIN | Not yet assigned | — |
Medicinal ingredients
- CLAVULANATE POTASSIUM 31.25 MG per 5ML
- AMOXICILLIN TRIHYDRATE 125 MG per 5ML
- CLAVULANATE POTASSIUM 28.5 MG per 5ML
- AMOXICILLIN TRIHYDRATE 200 MG per 5ML
- CLAVULANATE POTASSIUM 62.5 MG per 5ML
- AMOXICILLIN TRIHYDRATE 250 MG per 5ML
- CLAVULANATE POTASSIUM 57 MG per 5ML
- AMOXICILLIN TRIHYDRATE 400 MG per 5ML