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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 211809

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NDA 211809 describes ETHACRYNIC ACID, which is a drug marketed by Adaptis, Agnitio, Alvogen, Amneal Pharms Co, Chartwell Rx, Hikma, Lupin Ltd, Ph Health, Sciegen Pharms Inc, and Upsher Smith Labs, and is included in ten NDAs. It is available from eight suppliers. Additional details are available on the ETHACRYNIC ACID profile page.

The generic ingredient in ETHACRYNIC ACID is ethacrynic acid. There are thirteen drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the ethacrynic acid profile page.

Summary for 211809

Tradename:	ETHACRYNIC ACID
Applicant:	Agnitio
Ingredient:	ethacrynic acid
Patents:	0

Pharmacology for NDA: 211809

Physiological Effect	Increased Diuresis at Loop of Henle

Medical Subject Heading (MeSH) Categories for 211809

Diuretics
Enzyme Inhibitors

Suppliers and Packaging for NDA: 211809

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ETHACRYNIC ACID	ethacrynic acid	TABLET;ORAL	211809	ANDA	TRUPHARMA LLC	52817-367	52817-367-10	100 TABLET in 1 BOTTLE (52817-367-10)
ETHACRYNIC ACID	ethacrynic acid	TABLET;ORAL	211809	ANDA	TRUPHARMA LLC	52817-367	52817-367-90	90 TABLET in 1 BOTTLE (52817-367-90)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	25MG
Approval Date:	Jul 12, 2019	TE:	AB	RLD:	No

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