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Last Updated: January 4, 2025

Details for New Drug Application (NDA): 018902

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NDA 018902 describes FUROSEMIDE, which is a drug marketed by Abraxis Pharm, Accord Hlthcare, Am Regent, Amneal Pharms Co, Areva Pharms, Astrazeneca, Avet Lifesciences, Baxter Hlthcare Corp, Eugia Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, 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, Wyeth Ayerst, Pharmobedient Cnsltg, Ani Pharms, Chartwell Rx, Epic Pharma Llc, Esjay Pharma, Graviti Pharms, Ipca Labs Ltd, Kalapharm, Leading, Mylan, Prinston Inc, Sun Pharm Inds Inc, Sun Pharm Industries, Superpharm, and Watson Labs Teva, and is included in sixty-five NDAs. It is available from forty-nine 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 suppliers are listed for this compound. Additional details are available on the furosemide profile page.

Summary for 018902

Tradename:	FUROSEMIDE
Applicant:	Fresenius Kabi Usa
Ingredient:	furosemide
Patents:	0

Pharmacology for NDA: 018902

Physiological Effect	Increased Diuresis at Loop of Henle

Medical Subject Heading (MeSH) Categories for 018902

Diuretics
Sodium Potassium Chloride Symporter Inhibitors

Suppliers and Packaging for NDA: 018902

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
FUROSEMIDE	furosemide	INJECTABLE;INJECTION	018902	NDA	HF Acquisition Co LLC, DBA HealthFirst	51662-1572	51662-1572-1	2 mL in 1 VIAL (51662-1572-1)
FUROSEMIDE	furosemide	INJECTABLE;INJECTION	018902	NDA	HF Acquisition Co LLC, DBA HealthFirst	51662-1572	51662-1572-3	25 POUCH in 1 CASE (51662-1572-3) / 1 VIAL in 1 POUCH (51662-1572-2) / 2 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	10MG/ML
Approval Date:	May 22, 1984	TE:	AP	RLD:	No

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