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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 218831

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NDA 218831 describes FUROSEMIDE, which is a drug marketed by Abraxis Pharm, Accord Hlthcare, Am Regent, Amneal Pharms Co, 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, Saba Ilac Sanayive, Sagent, Smith And Nephew, Warner Chilcott, Watson Labs, Wockhardt Bio Ag, 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-seven NDAs. It is available from fifty-four 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. Fifty-seven suppliers are listed for this compound. Additional details are available on the furosemide profile page.

Summary for 218831

Tradename:	FUROSEMIDE
Applicant:	Aurobindo Pharma Ltd
Ingredient:	furosemide
Patents:	0

Pharmacology for NDA: 218831

Physiological Effect	Increased Diuresis at Loop of Henle

Medical Subject Heading (MeSH) Categories for 218831

Diuretics
Sodium Potassium Chloride Symporter Inhibitors

Suppliers and Packaging for NDA: 218831

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
FUROSEMIDE	furosemide	TABLET;ORAL	218831	ANDA	Aurobindo Pharma Limited	59651-796	59651-796-01	100 TABLET in 1 BOTTLE (59651-796-01)
FUROSEMIDE	furosemide	TABLET;ORAL	218831	ANDA	Aurobindo Pharma Limited	59651-796	59651-796-99	1000 TABLET in 1 BOTTLE (59651-796-99)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	20MG
Approval Date:	Jul 17, 2025	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	40MG
Approval Date:	Jul 17, 2025	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	80MG
Approval Date:	Jul 17, 2025	TE:	AB	RLD:	No

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