ANDA 207758, held by Zydus Pharms. Ethacrynate Sodium.
As of Nov 15, 2026, ANDA 207758 (Ethacrynate Sodium), held by Zydus Pharms, was first approved by FDA on Nov 17, 2017, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 17, 2017 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Ethacrynate SodiumEQ 50MG BASE/VIAL ยท injectable;injection | Ethacrynate Sodium | Rx |
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