NITROSTAT (nitroglycerin) · Viatris
NITROSTAT is FDA-approved to treat 2 conditions (same as NITROGLYCERIN).
Details
- Status
- Prescription
- First Approved
- 1987-01-08
- Routes
- SUBLINGUAL, INJECTION
- Dosage Forms
- TABLET, INJECTABLE
NITROSTAT Approval History
What NITROSTAT Treats
2 indicationsNITROSTAT is approved for 2 conditions since its original approval in 1987. These indications span multiple therapeutic areas including oncology, immunology, and more.
Same approved indications as NITROGLYCERIN (same active ingredient).
Viatris's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
Clinical Trial Registry
14 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT02425566 | 141218 | Ph 1 | active not recruiting | Role of Sympathetic Activity and Splanchnic Capacitance in Hypertension |
| NCT03689946 results posted | 54274 | Ph 3 | completed | Effect of Evolocumab on Coronary Atherosclerosis |
| NCT02209636 results posted | CLNB-006-13F CX001030 | Ph 4 | completed | Phosphate Lowering in CKD Trial |
| NCT02617550 VENICE | 17849 2015-001444-11 | Ph 1 | completed | Vericiguat Drug-drug Interaction With Nitroglycerin in Stable Coronary Artery Disease Patients |
| NCT03716050 results posted | IRB00038262 | Ph 2, Ph 3 | terminated | The Effect of Nitroglycerin Ointment, Fluorescent Angiography, and Incisional Negative Pressure Wound Therapy on Mastectomy Skin Flap Perfusion-Related Problems |
| NCT03809065 | N53-2016 | Ph 4 | completed | Effects of Nitroglycerin Versus Labetalol on Tissue Perfusion During Deliberate Hypotension |
| NCT03296670 | LSG1501104 | Ph 4 | completed | Efficacy of Intracoronary Infusion of Different Medicine in STEMI Patients With CSFP |
| NCT04220281 prop | RGAbusinna | Ph 1, Ph 2 | terminated | Comparison Between Two Drugs (Propofol and Nitroglycerin as a Hypotensive Agents During Endoscopic Sinus Surgery |
| NCT02961946 results posted | 2016P002417 | Ph 4 | completed | Effects of Sublingual and Transdermal Administration of Nitroglycerin for Coronary CT Angiography on Image Quality |
| NCT03622060 NONERAO | HerminaHCK | Ph 3 | completed | Intraarterial Nitroglycerin Versus Nicardipine and Radial Artery Occlusion |
| NCT02343276 results posted | ICSC-2015 | Ph 3 | completed | Randomized Clinical Trial Comparing Transradial Catheterization With or Without Spasmolytic Drugs |
| NCT02327793 PATIS | PATIS Version 1.0 | Ph 2 | completed | Perfusion and Antihypertensive Therapy in Acute Ischemic Stroke |
| NCT02254252 results posted | 12604 | Ph 4 | completed | Effects of Nicorandil on Angina Symptoms in Patients With Coronary Slow Flow |
| NCT07682454 | 26323 NCI-2026-04001 | Ph 2 | not yet recruiting | Utilize Imaging to Assess Changes in Hepatocellular Carcinoma Perfusion as Potentiated by Intra-Arterial Nitroglycerin |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
NITROSTAT FDA Label Details
Indications & Usage
FDA Label (PDF)NITROSTAT is FDA-approved to treat 2 conditions — same approved indications as NITROGLYCERIN.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.