Tirofiban Hydrochloride

For non-ST elevation acute coronary syndrome (NSTE-ACS). Sold as Aggrastat. Every FDA application for this active ingredient: 2 branded and 3 generic.

As of Nov 15, 2026, FDA lists 5 applications for Tirofiban Hydrochloride (sold as Aggrastat), first approved May 14, 1998, with 1 new use approved and 0 published complete response letters.

First approved: May 14, 1998
Applications: 5
New uses approved: 1
Complete response letters: 0

Clinical Trials

1 open or ongoing study names this ingredient as an intervention, including as a comparator; newest first. See all

Study	Phase	Status	Posted
Early Administration of Tirofiban in Patients Treated With Tenecteplase for Acute Ischemic StrokeAcute Ischemic Stroke · Second Affiliated Hospital of Guangxi Medical University	Phase 3	Recruiting	Nov 3, 2022

Applications

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


May 14, 1998	AggrastatNDA 20912 · New molecular entity	Medicure	18	Marketed
May 14, 1998	AggrastatNDA 20913 · New dosage form	Medicure	16	Marketed
Apr 8, 2021	Tirofiban HydrochlorideANDA 206888	Gland	0	Marketed
May 1, 2023	Tirofiban HydrochlorideANDA 216379	Eugia Pharma	0	Marketed
Jul 24, 2023	Tirofiban HydrochlorideANDA 213947	Nexus	0	Marketed

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