Approval · Notice of Compliance 10285 · 2009
ONDANSETRON: Notice of Compliance 10285
Issued June 23, 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
- 10285
- Date
- June 23, 2009
- Company
- Pro Doc LimiteeLaval, Quebec, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Abbreviated New Drug Submission (ANDS)
- Submission class
- Admin
- Reason
- New manufacturer and product name
- Therapeutic class
- 5-ht3 receptor antagonist
- Canadian reference product
- ZOFRAN (Glaxosmithkline Inc)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| ONDANSETRON | 02325160 | Marketed |
Medicinal ingredients
- ONDANSETRON HYDROCHLORIDE DIHYDRATE 8 MG per TAB