Last Updated: May 2, 2026

Details for New Drug Application (NDA): 018569

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NDA 018569 describes FUROSEMIDE, which is a drug marketed by Abraxis Pharm, Accord Hlthcare, Am Regent, Amneal Pharms Co, Apotex, Areva Pharms, Aspiro, Astrazeneca, Avet Lifesciences, Baxter Hlthcare Corp, Eugia Pharma, Fresenius Kabi Usa, Gland, Hikma, Hospira, Igi Labs Inc, Intl Medication, Mankind Pharma, Marsam Pharms Llc, Meitheal, Micro Labs, Saba Ilac Sanayive, Sagent, Smith And Nephew, Warner Chilcott, Watson Labs, Wyeth Ayerst, Pharmobedient Cnsltg, Ani Pharms, Aurobindo Pharma Ltd, Chartwell Rx, Epic Pharma Llc, Esjay Pharma, Graviti Pharms, Ipca Labs Ltd, Kalapharm, Leading, Pharmobedient, Prinston Inc, Sun Pharm Inds Inc, Sun Pharm Industries, Superpharm, and Watson Labs Teva, and is included in sixty-eight NDAs. It is available from fifty-seven suppliers. Additional details are available on the FUROSEMIDE profile page.

The generic ingredient in FUROSEMIDE is furosemide. There are twenty-two drug master file entries for this compound. Sixty suppliers are listed for this compound. Additional details are available on the furosemide profile page.

Summary for 018569

Tradename:	FUROSEMIDE
Applicant:	Epic Pharma Llc
Ingredient:	furosemide
Patents:	0

Pharmacology for NDA: 018569

Physiological Effect	Increased Diuresis at Loop of Henle

Medical Subject Heading (MeSH) Categories for 018569

Diuretics
Sodium Potassium Chloride Symporter Inhibitors

Suppliers and Packaging for NDA: 018569

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
FUROSEMIDE	furosemide	TABLET;ORAL	018569	NDA	Marlex Pharmaceuticals, Inc.	10135-832	10135-832-01	100 TABLET in 1 BOTTLE (10135-832-01)
FUROSEMIDE	furosemide	TABLET;ORAL	018569	NDA	Marlex Pharmaceuticals, Inc.	10135-832	10135-832-10	1000 TABLET in 1 BOTTLE (10135-832-10)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	40MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	20MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:	AB	RLD:	No

Profile for product number 005

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	80MG
Approval Date:	Aug 14, 1984	TE:	AB	RLD:	No

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