Overview
A barbiturate with hypnotic and sedative properties (but not antianxiety). Adverse effects are mainly a consequence of dose-related CNS depression and the risk of dependence with continued use is high. (From Martindale, The Extra Pharmacopoeia, 30th ed, p565)
Background
A barbiturate with hypnotic and sedative properties (but not antianxiety). Adverse effects are mainly a consequence of dose-related CNS depression and the risk of dependence with continued use is high. (From Martindale, The Extra Pharmacopoeia, 30th ed, p565)
Indication
中效催眠药，主要用于催眠、镇静、抗惊厥以及麻醉前给药。
Associated Conditions
No associated conditions information available.
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/01/03 | Not Applicable | Recruiting | |||
2024/04/26 | Phase 4 | Not yet recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Bausch Health US, LLC | 0187-4303 | INTRAMUSCULAR, INTRAVENOUS | 0.5 g in 5 mL | 7/1/2020 |
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 |
|---|---|---|---|---|---|
| Amobarbital Tablets | 国药准字H37020271 | 化学药品 | 片剂 | 2/17/2025 | |
| Amobarbital Tablets | 国药准字H44020378 | 化学药品 | 片剂 | 1/25/2021 | |
| 注射用异戊巴比妥钠 | 国药准字H31021724 | 化学药品 | 注射剂 | 8/13/2020 | |
| 注射用异戊巴比妥钠 | 国药准字H31021725 | 化学药品 | 注射剂 | 8/13/2020 |
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 |
|---|---|---|---|---|---|
| AMYTAL SODIUM 500mg powder for injection | 14617 | Medicine | A | 9/5/1991 |