Prevents angina pectoris due to coronary artery disease. Sold as Isordil, Sorbitrate, Dilatrate-Sr. Every FDA application for this active ingredient: 7 branded and 34 generic.
As of Nov 13, 2026, FDA lists 41 applications for Isosorbide Dinitrate (sold as Isordil, Sorbitrate, Dilatrate-Sr), first approved Nov 9, 1959, with 0 new uses approved and 0 published complete response letters.
| Product | Part | Spending, 2025 | Change | Beneficiaries |
|---|---|---|---|---|
| Isosorbide Dinitrate | Part D | $25.9M | -9% | 133,638 |
| Isordil | Part D | $0K | -100% | 0 |
| Isordil Titradose | Part D | $0K | -100% | 0 |
| Study | Phase | Status | Posted |
|---|---|---|---|
| Efficacy of A Non-Invasive Botulinum Toxin Microneedle Pad for the Treatment of Secondary Raynaud's PhenomenonSystemic Sclerosis (SSc), Raynaud Disease Secondary to Scleroderma · Khon Kaen University | Phase 3 | Not yet recruiting | Aug 12, 2026 |
| Vasodilator Therapy With Isosorbide Mononitrate or Diltiazem to Reduce Vasotoxicity in Patients With Gastrointestinal Cancer Receiving Fluoropyrimidine TherapyMalignant Digestive System Neoplasm · Mayo Clinic | Phase 1 / Phase 2 | Recruiting | Mar 9, 2026 |
| Isosorbide Mononitrate and Butylphthalide to Reduce the Risk of Disability in Patients With Acute Lacunar Stroke (IMPACT)Stroke, Lacunar, Stroke, Acute Ischemic · Beijing Tiantan Hospital | Phase 3 | Not yet recruiting | Nov 26, 2025 |
| Cervical Ripening With Misoprostol vs Isosorbide Mononitrate ; A Parallel -Arm Randomized Controlled TrialCervical Ripening · Raid M. Al-Ani | Not applicable | Active, not recruiting | Aug 13, 2025 |
| Efficacy and Safety of Isosorbide Oral Solution in Patients With Meniere's DiseaseMeniere´s Disease · Lunan Better Pharmaceutical Co., LTD. | Phase 2 / Phase 3 | Not yet recruiting | Jan 9, 2025 |
| The FOCUS-ADHF RegistryAcute Heart Failure With Reduced Ejection Fraction, Decompensation; Heart, Congestive · ASL Città di Torino | — | Recruiting | Dec 10, 2024 |
| Antiplatelet Therapy and Endothelial-stabilizing Agents in Cerebral Small Vessel DiseasesStroke, Ischemic, Small Vessel Cerebrovascular Disease · The First Affiliated Hospital with Nanjing Medical University | — | Recruiting | Dec 4, 2024 |
| Diuretics vs. Afterload Reduction for Treatment of HeartLogic AlertsHeart Failure, Congestive · Heart Center Research, LLC | Phase 4 | Recruiting | Jan 23, 2024 |
| Approved | Application | Sponsor | Supplements | Marketing |
|---|---|---|---|---|
| Nov 9, 1959 | IsordilNDA 12093 · New molecular entity | Bausch | 8 | Marketed |
| Dec 20, 1961 | IsordilNDA 12940 · New formulation or manufacturer | Biovail | 7 | Discontinued |
| Jan 16, 1968 | SorbitrateNDA 16192 · New formulation or manufacturer | Astrazeneca | 5 | Discontinued |
| Dec 7, 1970 | SorbitrateNDA 16776 · New dosage form | Astrazeneca | 5 | Discontinued |
| Dec 1, 1978 | Isosorbide DinitrateANDA 84204 | Sun Pharm Industries | 15 | Discontinued |
| Feb 17, 1987 | Isosorbide DinitrateANDA 89190 | Superpharm | 0 | Discontinued |
| Feb 17, 1987 | Isosorbide DinitrateANDA 89191 | Superpharm | 0 | Discontinued |
| Feb 17, 1987 | Isosorbide DinitrateANDA 89192 | Superpharm | 0 | Discontinued |
| Mar 12, 1987 | Isosorbide DinitrateANDA 86925 | Ph Health | 16 | Marketed |
| Mar 12, 1987 | Isosorbide DinitrateANDA 87946 | Ph Health | 9 | Marketed |
| Mar 12, 1987 | Isosorbide DinitrateANDA 86923 | Ph Health | 13 | Marketed |
| Sep 29, 1987 | Isosorbide DinitrateANDA 86031 | Watson Labs Teva | 12 | Discontinued |
| Oct 2, 1987 | Isosorbide DinitrateANDA 87537 | Ph Health | 10 | Marketed |
| Nov 2, 1987 | Isosorbide DinitrateANDA 88088 | Hikma | 25 | Marketed |
| Nov 2, 1987 | Isosorbide DinitrateANDA 86055 | Hikma | 23 | Discontinued |
| Jan 6, 1988 | Isosorbide DinitrateANDA 86034 | Watson Labs | 15 | Discontinued |
| Jan 7, 1988 | Isosorbide DinitrateANDA 86223 | Sandoz | 25 | Marketed |
| Jan 7, 1988 | Isosorbide DinitrateANDA 86032 | Ani Pharms | 15 | Discontinued |
| Jan 7, 1988 | Isosorbide DinitrateANDA 86221 | Sandoz | 28 | Marketed |
| Feb 19, 1988 | Isosorbide DinitrateANDA 86222 | Sandoz | 17 | Discontinued |
| Feb 19, 1988 | Isosorbide DinitrateANDA 86225 | Sandoz | 15 | Discontinued |
| Feb 26, 1988 | Isosorbide DinitrateANDA 86033 | Watson Labs | 12 | Discontinued |
| Apr 7, 1988 | Isosorbide DinitrateANDA 89367 | Sandoz | 15 | Marketed |
| Sep 2, 1988 | Dilatrate-SrNDA 19790 · New formulation or manufacturer | Endo Operations | 10 | Discontinued |
| Dec 30, 1998 | Isosorbide DinitrateANDA 40009 | Sun Pharm Inds Inc | 3 | Discontinued |
| Jan 10, 2007 | Isosorbide DinitrateANDA 40591 | Hikma | 0 | Discontinued |
| Mar 17, 2008 | Isosorbide DinitrateANDA 40723 | Impax Labs Inc | 0 | Discontinued |
| Nov 20, 2019 | Isosorbide DinitrateANDA 213057 | Zydus Lifesciences | 0 | Marketed |
| Nov 23, 2021 | Isosorbide DinitrateANDA 211290 | Ph Health | 0 | Marketed |
| Jul 8, 2022 | Isosorbide DinitrateANDA 215723 | Rubicon Research | 0 | Marketed |
| — | IsordilNDA 12882 | Wyeth Ayerst | 7 | Discontinued |
| — | SorbitrateNDA 16191 | Astrazeneca | 0 | Discontinued |
| — | Isosorbide DinitrateANDA 86168 | Sun Pharm Industries | 1 | Discontinued |
| — | Isosorbide DinitrateANDA 86166 | Sun Pharm Industries | 14 | Discontinued |
| — | Isosorbide DinitrateANDA 86167 | Sun Pharm Industries | 18 | Discontinued |
| — | SorbitrateANDA 86405 | Astrazeneca | 0 | Discontinued |
| — | Isosorbide DinitrateANDA 87545 | Sun Pharm Industries | 11 | Discontinued |
| — | Isosorbide DinitrateANDA 87564 | Sun Pharm Industries | 11 | Discontinued |
| — | SorbitrateANDA 88124 | Astrazeneca | 0 | Discontinued |
| — | SorbitrateANDA 88125 | Astrazeneca | 0 | Discontinued |
| — | Isosorbide DinitrateANDA 86169 | Sun Pharm Industries | 15 | Discontinued |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
Astrazeneca
Sandoz
Zydus Lifesciences