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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 208805

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NDA 208805 describes ETHACRYNIC ACID, which is a drug marketed by Adaptis, Agnitio, Alvogen, Amneal Pharms Co, Chartwell Rx, Endo Operations, Hikma, Lupin Ltd, 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 208805

Tradename:	ETHACRYNIC ACID
Applicant:	Amneal Pharms Co
Ingredient:	ethacrynic acid
Patents:	0

Pharmacology for NDA: 208805

Physiological Effect	Increased Diuresis at Loop of Henle

Medical Subject Heading (MeSH) Categories for 208805

Diuretics
Enzyme Inhibitors

Suppliers and Packaging for NDA: 208805

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ETHACRYNIC ACID	ethacrynic acid	TABLET;ORAL	208805	ANDA	Amneal Pharmaceuticals NY LLC	69238-1126	69238-1126-1	100 TABLET in 1 BOTTLE (69238-1126-1)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	25MG
Approval Date:	May 8, 2018	TE:	AB	RLD:	No

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