Approval · Notice of Compliance 3548 · 2003
AMBIEN: Notice of Compliance 3548
Issued September 4, 2003
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
- 3548
- Date
- September 4, 2003
- Company
- Lorex PharmaceuticalsSkokie, Illinois, United States
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Product monograph updates for the addition of information from clinical trials to describe the efficacy of zolpidem and for the re-location of statements on the indications section to the warnings section
- Therapeutic class
- Hypnotic agent
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| AMBIEN | Not yet assigned | — |
Medicinal ingredients
- ZOLPIDEM TARTRATE 5 MG per TAB
- ZOLPIDEM TARTRATE 10 MG per TAB