ANDA 204634, held by Mylan Institutional. Ethacrynate Sodium.
As of Nov 15, 2026, ANDA 204634 (Ethacrynate Sodium), held by Mylan Institutional, was first approved by FDA on Aug 23, 2016, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 23, 2016 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Ethacrynate SodiumEQ 50MG BASE/VIAL ยท injectable;injection | Ethacrynate Sodium | 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
