Overview
A benzodiazepine derivative used mainly as a hypnotic.
Indication
For short-term and intermittent use in patients with recurring insomnia and poor sleeping habits
Associated Conditions
- Insomnia
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2015/03/02 | Phase 3 | Terminated | |||
2015/01/29 | Phase 1 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Chartwell RX, LLC | 62135-736 | ORAL | 15 mg in 1 1 | 12/19/2023 | |
| Chartwell RX, LLC | 62135-737 | ORAL | 30 mg in 1 1 | 12/19/2023 | |
| Rebel Distributors Corp | 21695-363 | ORAL | 30 mg in 1 1 | 12/15/2009 | |
| Physicians Total Care, Inc. | 54868-0092 | ORAL | 15 mg in 1 1 | 6/3/2013 | |
| Physicians Total Care, Inc. | 54868-0093 | ORAL | 30 mg in 1 1 | 6/3/2013 | |
| H.J. Harkins Company, Inc. | 52959-236 | ORAL | 30 mg in 1 1 | 12/6/2011 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Capsulae Flurazepami Monohydrochloridi | 国药准字H11020896 | 化学药品 | 胶囊剂 | 12/11/2020 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
Help Us Improve
Your feedback helps us provide better drug information and insights.