Approval · Notice of Compliance 9502 · 2008
ONDANSETRON-ODAN: Notice of Compliance 9502
Issued April 22, 2008
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
- 9502
- Date
- April 22, 2008
- Company
- Odan Laboratories Ltd.
- Product type
- Prescription Pharmaceutical
- Submission
- Abbreviated New Drug Submission (ANDS)
- Submission class
- Admin
- Reason
- New manufacturer and product name
- Therapeutic class
- Antiemetic (5-ht3 receptor antagonist)
- Canadian reference product
- ZOFRAN (ONDANSETRON 8MG TABLETS) (Glaxosmithkline Inc)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| ONDANSETRON-ODAN | 02306212 | Cancelled Post Market |
| ONDANSETRON-ODAN | 02306220 | Cancelled Post Market |
Medicinal ingredients
- ONDANSETRON HCL 4 MG per TAB
- ONDANSETRON HCL 8 MG per TAB