Drugs / Ambien CR
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | AMBIEN CR | — | 2007-12-20 | fda.gov ↗ |
| Approved | US (FDA) | AMBIEN CR | — | 2005-09-02 | fda.gov ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 2 | NCT00683436 | May → Oct 2008 | insomnia | Neurogen Corporation | Terminated | No outcome recorded |
Evidence & citations 1 cited value
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Ambien CR | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00683436 ↗ |