Treats acute coronary syndrome (ACS) managed medically or with percutaneous coronary…. ANDA 209864, held by Hainan Poly. Eptifibatide.
As of Nov 14, 2026, ANDA 209864 (Eptifibatide), held by Hainan Poly, was first approved by FDA on Jan 25, 2019, 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 |
|---|---|---|---|
| Jan 25, 2019 | Original application | Approved | None posted |
| Eptifibatide2MG/ML · injectable;injection | Eptifibatide | Rx |
| Eptifibatide75MG/100ML · injectable;injection | Eptifibatide | Rx |
| Nov 19, 2024 | Supplement 2Labeling · Standard review | Approved | None posted |
| Jan 25, 2019 | 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
