Last Updated: September 24, 2026

Details for New Drug Application (NDA): 208501

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NDA 208501 describes ETHACRYNIC ACID, which is a drug marketed by Adaptis, Agnitio, Alvogen, Amneal Pharms Co, Chartwell Rx, Hikma, Lupin, Ph Health, Sciegen Pharms, 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 is one drug master file entry for this compound. Ten suppliers are listed for this compound. Additional details are available on the ethacrynic acid profile page.

Summary for 208501

Tradename:	ETHACRYNIC ACID
Applicant:	Ph Health
Ingredient:	ethacrynic acid
Patents:	0

Medical Subject Heading (MeSH) Categories for 208501

Diuretics
Enzyme Inhibitors

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	25MG
Approval Date:	Jul 21, 2017	TE:		RLD:	No

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