Overview
A vasodilator used in the treatment of angina pectoris. Its actions are similar to nitroglycerin but with a slower onset of action.
Indication
For the prevention of angina pectoris due to coronary artery disease.
Associated Conditions
- Angina Pectoris
- Heart Failure
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/05/06 | Phase 4 | Completed | |||
2024/01/23 | Phase 4 | Recruiting | |||
2022/03/11 | Phase 4 | Recruiting | Johannes Grand | ||
2020/03/05 | Phase 2 | Completed | |||
2016/06/02 | Phase 3 | Completed | |||
2016/03/24 | Not Applicable | UNKNOWN | Chinese PLA General Hospital | ||
2016/01/08 | Not Applicable | Withdrawn | |||
2015/07/02 | Phase 4 | Completed | National Institute of Perinatology | ||
2015/02/23 | Not Applicable | UNKNOWN | |||
2015/01/22 | Phase 3 | UNKNOWN |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Bausch Health US LLC | 0187-0152 | ORAL | 5 mg in 1 1 | 8/8/2019 | |
| Advagen Pharma Ltd | 72888-081 | ORAL | 5 mg in 1 1 | 7/13/2022 | |
| Zydus Lifesciences Limited | 70771-1504 | ORAL | 30 mg in 1 1 | 11/7/2023 | |
| Zydus Lifesciences Limited | 70771-1502 | ORAL | 10 mg in 1 1 | 11/7/2023 | |
| REMEDYREPACK INC. | 70518-3444 | ORAL | 10 mg in 1 1 | 1/11/2024 | |
| Wilshire Pharmaceuticals | 52536-006 | ORAL | 20 mg in 1 1 | 6/30/2020 | |
| State of Florida DOH Central Pharmacy | 53808-0274 | ORAL | 10 mg in 1 1 | 6/3/2010 | |
| Zydus Pharmaceuticals (USA) Inc. | 70710-1148 | ORAL | 5 mg in 1 1 | 11/7/2023 | |
| Par Pharmaceutical, Inc. | 49884-556 | ORAL | 40 mg in 1 1 | 12/21/2021 | |
| Carilion Materials Management | 68151-2476 | ORAL | 30 mg in 1 1 | 1/30/2017 |
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 |
|---|---|---|---|---|---|
| APO-ISDN TABLET 5 mg | SIN01139P | TABLET | 5 mg | 5/13/1988 | |
| AA PHARMA ISDN TABLET 10 mg | SIN00055P | TABLET | 10 mg | 2/24/1988 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Isosorbide Dinitrate and Sodium Chloride Injection | 国药准字H19980047 | 化学药品 | 注射剂 | 9/1/2020 | |
| Isosorbide Dinitrate and Sodium Chloride Injection | 国药准字H20000572 | 化学药品 | 注射剂 | 9/3/2020 | |
| Isosorbide Dinitrate and Sodium Chloride Injection | 国药准字H19980198 | 化学药品 | 注射剂 | 9/29/2020 | |
| 硝酸异山梨酯缓释胶囊 | 国药准字H19990009 | 化学药品 | 缓释胶囊 | 8/17/2020 | |
| 硝酸异山梨酯缓释胶囊 | 国药准字H19990008 | 化学药品 | 缓释胶囊 | 8/19/2020 | |
| Isosorbide Dinitrate Sustained-release Tablets | 国药准字H45021137 | 化学药品 | 片剂 | 8/23/2020 | |
| Isosorbide Dinitrate Sustained-release Tablets | 国药准字H37023441 | 化学药品 | 片剂 | 2/12/2020 | |
| Isosorbide Dinitrate Sustained-release Tablets | 国药准字H42022359 | 化学药品 | 片剂 | 9/8/2020 | |
| Isosorbide Dinitrate Aerosol | 国药准字H37022650 | 化学药品 | 气雾剂 | 1/16/2020 | |
| Isosorbide Dinitrate Aerosol | 国药准字H10870015 | 化学药品 | 气雾剂 | 3/23/2021 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| APT-ISOSORBIDE DINITRATE TABLETS 10MG | N/A | N/A | N/A | 3/27/2025 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| ISORDIL 10mg tablet bottle | 40258 | Medicine | A | 7/22/1992 | |
| ISORDIL 10mg tablet blister pack | 40257 | Medicine | A | 7/22/1992 | |
| ISORDIL 40mg tablet bottle | 40250 | Medicine | A | 7/28/1992 | |
| ISORDIL 40mg tablet blister pack | 40251 | Medicine | A | 7/22/1992 | |
| ISORDIL 30mg tablet blister pack | 40248 | Medicine | A | 7/22/1992 | |
| ISORDIL 5mg tablet | 12957 | Medicine | A | 8/19/1991 | |
| ISORDIL 30mg tablet bottle | 40249 | Medicine | A | 7/22/1992 |
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