Approval · Notice of Compliance 13769 · 2012
ESOMEPRAZOLE: Notice of Compliance 13769
Issued October 25, 2012
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
- 13769
- Date
- October 25, 2012
- Company
- Pro Doc LimiteeLaval, Quebec, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Abbreviated New Drug Submission (ANDS)
- Submission class
- Admin
- Reason
- New macufacturer and product name
- Therapeutic class
- H+,K+-atpase inhibitor
- Canadian reference product
- NEXIUM (Astrazeneca Canada Inc)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| ESOMEPRAZOLE | 02394839 | Marketed |
| ESOMEPRAZOLE | 02394847 | Marketed |
Medicinal ingredients
- ESOMEPRAZOLE MAGNESIUM 20 MG per TAB
- ESOMEPRAZOLE MAGNESIUM 40 MG per TAB