Approval · Notice of Compliance 11564 · 2010
ONDANSETRON: Notice of Compliance 11564
Issued June 28, 2010
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
- 11564
- Date
- June 28, 2010
- Company
- AA Pharma Inc.Toronto, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Abbreviated New Drug Submission (ANDS)
- Submission class
- Admin
- Reason
- Manufacturer and product name change
- Therapeutic class
- Antiemetic (5-HT3 receptor antagonist)
- Canadian reference product
- ZOFRAN (Glaxosmithkline Inc)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| ONDANSETRON | 02291967 | Marketed |
Medicinal ingredients
- ONDANSETRON HYDROCHLORIDE DIHYDRATE 4 MG per 5ML