Last Updated: August 8, 2026

Details for New Drug Application (NDA): 070434

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NDA 070434 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 sixty 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-three suppliers are listed for this compound. Additional details are available on the furosemide profile page.

Summary for 070434

Tradename:	FUROSEMIDE
Applicant:	Hikma
Ingredient:	furosemide
Patents:	0

Pharmacology for NDA: 070434

Physiological Effect	Increased Diuresis at Loop of Henle

Medical Subject Heading (MeSH) Categories for 070434

Diuretics
Sodium Potassium Chloride Symporter Inhibitors

Suppliers and Packaging for NDA: 070434

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
FUROSEMIDE	furosemide	SOLUTION;ORAL	070434	ANDA	Hikma Pharmaceuticals USA Inc.	0054-3294	0054-3294-46	60 mL in 1 BOTTLE (0054-3294-46)
FUROSEMIDE	furosemide	SOLUTION;ORAL	070434	ANDA	Hikma Pharmaceuticals USA Inc.	0054-3294	0054-3294-50	120 mL in 1 BOTTLE (0054-3294-50)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;ORAL			Strength	10MG/ML
Approval Date:	Apr 22, 1987	TE:		RLD:	No

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