Approval · Notice of Compliance 7268 · 2005
XYREM: Notice of Compliance 7268
Issued August 5, 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
- 7268
- Date
- August 5, 2005
- Company
- Orphan Medical Inc.
- Product type
- Prescription Pharmaceutical
- Submission
- New Drug Submission (NDS)
- Submission class
- New Active Substance (NAS)
- Therapeutic class
- Central nervous system depressant
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| XYREM | 02268272 | Marketed |
Medicinal ingredients
- SODIUM OXYBATE 500 MG per ML