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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 204634

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NDA 204634 describes ETHACRYNATE SODIUM, which is a drug marketed by Mylan Institutional, Ph Health, Sterimax, and Zydus Pharms, and is included in four NDAs. It is available from two suppliers. Additional details are available on the ETHACRYNATE SODIUM profile page.

The generic ingredient in ETHACRYNATE SODIUM is ethacrynate sodium. There are three drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the ethacrynate sodium profile page.

Summary for 204634

Tradename:	ETHACRYNATE SODIUM
Applicant:	Mylan Institutional
Ingredient:	ethacrynate sodium
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	EQ 50MG BASE/VIAL
Approval Date:	Aug 23, 2016	TE:		RLD:	No

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