Eptifibatide

ANDA 205557, held by Accord Hlthcare. Eptifibatide.

As of Nov 14, 2026, ANDA 205557 (Eptifibatide), held by Accord Hlthcare, was first approved by FDA on Nov 6, 2017, with 1 approved supplement and 0 published complete response letters.

First approved: Nov 6, 2017
Review: Standard
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Nov 6, 2017	Original application	Approved	None posted

Products

2 strengths and forms


Eptifibatide2MG/ML · injectable;injection	Eptifibatide	Discontinued
Eptifibatide75MG/100ML · injectable;injection	Eptifibatide	Discontinued

All 2 submissions, including labeling and manufacturing supplements


Jun 13, 2025	Supplement 3Labeling · Standard review	Approved	None posted
Nov 6, 2017	Original application	Approved	None posted

Identifiers

Application: ANDA 205557
Drugs@FDA: Overview at FDA
Company: Accord Healthcare

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