ANDA 204361, held by Usv. Eptifibatide.
As of Nov 14, 2026, ANDA 204361 (Eptifibatide), held by Usv, was first approved by FDA on Mar 14, 2019, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 14, 2019 | Original application | Approved | None posted |
| Eptifibatide2MG/ML · injectable;injection | Eptifibatide | Discontinued |
| Eptifibatide75MG/100ML · injectable;injection | Eptifibatide | Discontinued |
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
