Approval · Notice of Compliance 21672 · 2018
XIGDUO: Notice of Compliance 21672
Issued December 28, 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
- 21672
- Date
- December 28, 2018
- Company
- Astrazeneca Canada IncMississauga, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Additional manufacturer of the final intermediate and drug substance and additional API testing site.
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