Approval · Notice of Compliance 18544 · 2016
ESOMEPRAZOLE: Notice of Compliance 18544
Issued October 3, 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
- 18544
- Date
- October 3, 2016
- Company
- Ethypharm IncMontreal, Quebec, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Abbreviated New Drug Submission (ANDS)
- Submission class
- Labelling Only
- Reason
- Transfer of Drug Identification Number (DIN) and Product Name Change
- Canadian reference product
- NEXIUM (Astrazeneca Canada Inc)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| ESOMEPRAZOLE | 02417480 | Approved |
| ESOMEPRAZOLE | 02417499 | Approved |
Medicinal ingredients
- ESOMEPRAZOLE MAGNESIUM DIHYDRATE 20 MG per TAB
- ESOMEPRAZOLE MAGNESIUM DIHYDRATE 40 MG per TAB