Overview
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 |
|---|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|
| MOGADON nitrazepam 5mg tablet blister pack | 13751 | Medicine | A | 8/23/1991 | |
| Alodorm Nitrazepam 5mg tablet bottle | 54009 | Medicine | A | 11/14/1995 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| NITRAZEPAM-10 | PRO DOC LIMITEE | 02255588 | Tablet - Oral | 10 MG | 7/29/2004 |
| APO-NITRAZEPAM | 02245231 | Tablet - Oral | 10 MG | 9/17/2002 | |
| NITRAZEPAM-5 | PRO DOC LIMITEE | 02255561 | Tablet - Oral | 5 MG | 7/29/2004 |
| APO-NITRAZEPAM | 02245230 | Tablet - Oral | 5 MG | 9/17/2002 | |
| NITRAZADON | aa pharma inc | 02229654 | Tablet - Oral | 5 MG | 11/8/1996 |
| SANDOZ NITRAZEPAM | 02234003 | Tablet - Oral | 5 MG | 12/2/1997 | |
| SANDOZ NITRAZEPAM | 02234007 | Tablet - Oral | 10 MG | 12/2/1997 | |
| MOGADON | aa pharma inc | 00511528 | Tablet - Oral | 5 MG | 12/31/1980 |
| MOGADON | aa pharma inc | 00511536 | Tablet - Oral | 10 MG | 12/31/1980 |
| NITRAZADON | aa pharma inc | 02229655 | Tablet - Oral | 10 MG | 11/8/1996 |
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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