Treats acute coronary syndrome (ACS) managed medically or with percutaneous coronary…. ANDA 213081, held by Quagen. Eptifibatide.
As of Nov 14, 2026, ANDA 213081 (Eptifibatide), held by Quagen, was first approved by FDA on Sep 7, 2021, with 1 approved supplement and 0 published complete response letters.
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.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 7, 2021 | Original application | Approved | None posted |
| Eptifibatide2MG/ML · injectable;injection | Eptifibatide | Rx |
| Eptifibatide75MG/100ML · injectable;injection | Eptifibatide | Rx |
| Apr 20, 2022 | Supplement 1Manufacturing | Approved | None posted |
| Sep 7, 2021 | Original application | Approved | None posted |
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
