Approval · Notice of Compliance 15670 · 2014
ZOFRAN: Notice of Compliance 15670
Issued June 4, 2014
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
- 15670
- Date
- June 4, 2014
- Company
- Glaxosmithkline IncMississauga, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New information in the dosage and administration section as well as the action and clinical pharmacology
- Therapeutic class
- Antiemetic 5-ht1 receptor antagonist
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| ZOFRAN | Not yet assigned | — |
| ZOFRAN ODT | Not yet assigned | — |
Medicinal ingredients
- ONDANSETRON HYDROCHLORIDE DIHYDRATE 4 MG per TAB
- ONDANSETRON HYDROCHLORIDE DIHYDRATE 8 MG per TAB
- ONDANSETRON HYDROCHLORIDE DIHYDRATE 4 MG per 5ML
- ONDANSETRON HYDROCHLORIDE DIHYDRATE 2 MG per ML
- ONDANSETRON 4 MG per TAB
- ONDANSETRON 8 MG per TAB