Approval · Notice of Compliance 17992 · 2016
XIGDUO: Notice of Compliance 17992
Issued April 12, 2016
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
- 17992
- Date
- April 12, 2016
- Company
- Astrazeneca Canada IncMississauga, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New indications: for use in combination with a sulfonylurea and in combination with sitagliptin
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| XIGDUO | Not yet assigned | — |
Medicinal ingredients
- METFORMIN HYDROCHLORIDE 850 MG per TAB
- DAPAGLIFLOZIN 5 MG per TAB
- METFORMIN HYDROCHLORIDE 1,000 MG per TAB