Approval · Notice of Compliance 10688 · 2009
ONDANSETRON: Notice of Compliance 10688
Issued October 16, 2009
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
- 10688
- Date
- October 16, 2009
- Company
- Sandoz Canada Inc.Saint-Hubert, Quebec, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Abbreviated New Drug Submission (ANDS)
- Submission class
- Admin
- Reason
- Additional product name
- Therapeutic class
- Antiemetic (5-HT3-receptor antagonist)
- Canadian reference product
- ZOFRAN (Glaxo Wellcome Inc.)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| ONDANSETRON | 02334054 | — |
| ONDANSETRON | 02334062 | — |
Medicinal ingredients
- ONDANSETRON HYDROCHLORIDE DIHYDRATE 4 MG per TAB
- ONDANSETRON HYDROCHLORIDE DIHYDRATE 8 MG per TAB