Approval · Notice of Compliance 21168 · 2018
JANUMET: Notice of Compliance 21168
Issued July 31, 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
- 21168
- Date
- July 31, 2018
- Company
- Merck Canada IncKirkland, Quebec, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- addition of an alternate manufacturing process and an alternate drug substance manufacturing site
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| JANUMET | Not yet assigned | — |
Medicinal ingredients
- METFORMIN HYDROCHLORIDE 500 MG per TAB
- SITAGLIPTIN PHOSPHATE MONOHYDRATE 50 MG per TAB
- METFORMIN HYDROCHLORIDE 850 MG per TAB
- METFORMIN HYDROCHLORIDE 1,000 MG per TAB