Aspirin

Sold as 8-Hour Bayer, Measurin, Bayer Extra Strength Aspirin For Migraine Pain, Durlaza, Vazalore. Every FDA application for this active ingredient.

As of Nov 14, 2026, FDA lists 4 applications for Aspirin (sold as 8-Hour Bayer, Measurin, Bayer Extra Strength Aspirin For Migraine Pain and others), first approved Jun 25, 1965, with 0 new uses approved and 0 published complete response letters.

First approved: Jun 25, 1965
Applications: 4
New uses approved: 0
Complete response letters: 0

FDA Drug Safety Communications

One communication since 2020 that name this drug; see all communications

FDA recommends avoiding use of NSAIDs in pregnancy at 20 weeks or later because they can result in low amniotic fluidOct 15, 2020

Clinical Trials

427 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


Impact of Atrial Fibrillation Prediction Model on Prescribing Oral Anti-Coagulation in Patients With Cryptogenic StrokeStroke · Samir Saba	Not applicable	Not yet recruiting	Nov 13, 2026
Long-Term Sequential Dual Antiplatelet Therapy Based on Cilostazol in Symptomatic Intracranial Arterial Stenosis: A Real-World Cohort StudyIschemic Stroke, Symptomatic Intracranial Atherosclerotic Stenosis · Second Affiliated Hospital of Soochow University	—	Recruiting	Nov 13, 2026
Long-Term Sequential Dual Antiplatelet Therapy Based on Cilostazol in Symptomatic Intracranial Arterial StenosisIschemic Stroke, Symptomatic Intracranial Atherosclerotic Stenosis · Second Affiliated Hospital of Soochow University	Phase 4	Recruiting	Nov 12, 2026
Drug-coated Balloon Angioplasty For Ischemic Stroke Within 30 Days Caused By Intracranial Arterial Stenosis ( BASIS-2 )Intracranial Atherosclerotic Stenosis · Beijing Tiantan Hospital	Not applicable	Not yet recruiting	Nov 12, 2026
To Evaluate The Efficacy And Safety Of Rivaroxaban In Combination With Aspirin Compared With Aspirin Monotherapy In Patients With Stable Coronary Artery Disease (CAD) and High Ischemic RiskStable Coronary Artery Disease (CAD), Myocardial Infarction · Republican Specialized Scientific and Practical Medical Center of Cardiology	Not applicable	Not yet recruiting	Nov 10, 2026
Prophylactic Strategies for Mitigating Central Nervous System Relapse in Diffuse Large B-Cell LymphomaDiffuse Large B-Cell Lymphoma (DLBCL) · Cancer Institute and Hospital, Chinese Academy of Medical Sciences	Phase 2	Not yet recruiting	Nov 4, 2026
Aspirin vs. Rivaroxaban for Thromboprophylaxis in Multiple MyelomaMultiple Myeloma, Venous Thromboembolism (VTE) · Chen Lijuan	Phase 4	Recruiting	Oct 30, 2026
Effect of LMWH on Neonatal Outcomes in Isolated OligohydramniosOligohydramnios, Heparin · PAEC General Hospital, Islamabad	Phase 4	Recruiting	Oct 30, 2026

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Jun 25, 1965	8-Hour Bayer, MeasurinNDA 16030 · New dosage form	Bayer	25	Discontinued
Oct 18, 2001	Bayer Extra Strength Aspirin For Migraine PainNDA 21317 · TYPE 7	Bayer	0	Discontinued
Jan 14, 2013	VazaloreNDA 203697 · New dosage form	Plx Pharma	6	Marketed
Sep 4, 2015	DurlazaNDA 200671 · New dosage form	Hesp	2	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