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Treats acute coronary syndrome (ACS) managed medically or with percutaneous coronary…. ANDA 208554, held by Baxter Hlthcare Corp. Eptifibatide.
As of Nov 14, 2026, ANDA 208554 (Eptifibatide), held by Baxter Hlthcare Corp, was first approved by FDA on Nov 23, 2018, with 1 approved supplement and 0 published complete response letters.
First approved: Nov 23, 2018
Review: Standard
Supplements approved: 1
Complete response letters: 0
What It's For
From the FDA-approved label (Indications and Usage)
Eptifibatide injection is a platelet aggregation inhibitor indicated for:
Treatment of acute coronary syndrome (ACS) managed medically or with percutaneous coronary intervention (PCI)
Treatment of patients undergoing PCI (including intracoronary stenting) 1.1 Acute Coronary Syndrome (ACS) Eptifibatide injection is indicated to decrease the rate of a combined endpoint of death or new myocardial infarction (MI) in patients with ACS (unstable angina [UA]/non-ST-elevation myocardial infarction [NSTEMI]), including patients who are to be managed medically and those undergoing percutaneous coronary intervention (PCI). 1.
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters.Drugs@FDA and FDA complete response letters
