Approval · Notice of Compliance 30963 · 2023
SYNJARDY: Notice of Compliance 30963
Issued June 8, 2023
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
- 30963
- Date
- June 8, 2023
- Company
- Boehringer Ingelheim (Canada) Ltd.Burlington, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Additional Drug Product testing sites; Revision to Drug Product release and stability specifications; and new analytical methods
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| SYNJARDY | Not yet assigned | — |
Medicinal ingredients
- METFORMIN HYDROCHLORIDE 500 MG per TAB
- EMPAGLIFLOZIN 5 MG per TAB
- METFORMIN HYDROCHLORIDE 850 MG per TAB
- METFORMIN HYDROCHLORIDE 1,000 MG per TAB
- EMPAGLIFLOZIN 12.5 MG per TAB