Overview
A benzodiazepine derivative used as an anticonvulsant and hypnotic.
Background
A benzodiazepine derivative used as an anticonvulsant and hypnotic.
Indication
Used to treat short-term sleeping problems (insomnia), such as difficulty falling asleep, frequent awakenings during the night, and early-morning awakening.
Associated Conditions
- Insomnia
- Myoclonic seizures
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2015/03/02 | Phase 3 | Terminated | |||
2006/09/11 | Phase 3 | Completed | |||
2000/02/25 | Phase 2 | Completed | National Center for Research Resources (NCRR) |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| No FDA approvals found for this drug. | |||||
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 |
|---|---|---|---|---|---|
| Nitrazepam Tablets | 国药准字H13022197 | 化学药品 | 片剂 | 1/15/2021 | |
| Nitrazepam Tablets | 国药准字H37023055 | 化学药品 | 片剂 | 3/12/2020 | |
| Nitrazepam Tablets | 国药准字H32022966 | 化学药品 | 片剂 | 7/14/2020 | |
| Nitrazepam Tablets | 国药准字H42021542 | 化学药品 | 片剂 | 6/17/2020 | |
| Nitrazepam Tablets | 国药准字H42020239 | 化学药品 | 片剂 | 7/13/2020 | |
| Nitrazepam Tablets | 国药准字H34021994 | 化学药品 | 片剂 | 4/1/2021 | |
| Nitrazepam Tablets | 国药准字H14020302 | 化学药品 | 片剂 | 4/18/2022 | |
| Nitrazepam Tablets | 国药准字H41023108 | 化学药品 | 片剂 | 3/15/2023 |
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 |
|---|---|---|---|---|---|
| MOGADON nitrazepam 5mg tablet blister pack | 13751 | Medicine | A | 8/23/1991 | |
| Alodorm Nitrazepam 5mg tablet bottle | 54009 | Medicine | A | 11/14/1995 |