Approval · Notice of Compliance 28876 · 2022
EDARBI: Notice of Compliance 28876
Issued September 1, 2022
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
- 28876
- Date
- September 1, 2022
- Company
- Bausch Health, Canada Inc.Laval, Quebec, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Addition of nitrosamine testing to the drug product specification
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| EDARBI | Not yet assigned | — |
Medicinal ingredients
- AZILSARTAN MEDOXOMIL POTASSIUM 40 MG per TAB
- AZILSARTAN MEDOXOMIL POTASSIUM 80 MG per TAB