Approval · Notice of Compliance 7624 · 2005
ORZEL: Notice of Compliance 7624
Issued November 23, 2005
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
- 7624
- Date
- November 23, 2005
- Company
- Prempharm Inc.Etobicoke, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- New Drug Submission (NDS)
- Submission class
- Admin
- Reason
- Manufacturer name change
- Therapeutic class
- Antineoplastic agent, folic acid derivative
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| ORZEL | 02243681 | — |
Medicinal ingredients
- TEGAFUR 100 MG per CAP
- URACIL 224 MG per CAP
- LEUCOVORIN CALCIUM 15 MG per TAB