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 |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
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. | |||||
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| FLURAZEPAM 30MG CAPSULE | 02232657 | Capsule - Oral | 30 MG / CAP | N/A | |
| FLURAZEPAM 15MG CAPSULE | 02232656 | Capsule - Oral | 15 MG / CAP | N/A | |
| NOVO-FLUPAM CAP 30MG | novopharm limited | 00496553 | Capsule - Oral | 30 MG | 12/31/1980 |
| PMS-FLURAZEPAM CAP 30MG | 00667099 | Capsule - Oral | 30 MG / CAP | 12/31/1986 | |
| SOMNOL 15MG | axxess pharma inc. | 00483826 | Tablet - Oral | 15 MG | 12/31/1981 |
| SOM-PAM | biomed pharma | 00414220 | Capsule - Oral | 15 MG | 12/31/1981 |
| RIVA-FLURAZEPAM 15MG CAPSULES | laboratoire riva inc. | 02241281 | Capsule - Oral | 15 MG / CAP | 11/26/1999 |
| PMS-FLURAZEPAM CAP 15MG | 00667102 | Capsule - Oral | 15 MG | 12/31/1986 | |
| FLURAZEPAM 15 | PRO DOC LIMITEE | 00578479 | Capsule - Oral | 15 MG | 12/31/1982 |
| SOMNOL 30MG | axxess pharma inc. | 00483818 | Tablet - Oral | 30 MG | 12/31/1981 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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