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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 215856

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NDA 215856 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, Graviti Pharms, Ipca Labs Ltd, Kalapharm, Leading, Mylan, Prinston Inc, Strides Pharma, Sun Pharm Inds Inc, Sun Pharm Industries, Superpharm, and Watson Labs Teva, and is included in sixty-five 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-six suppliers are listed for this compound. Additional details are available on the furosemide profile page.

Summary for 215856

Tradename:	FUROSEMIDE
Applicant:	Saba Ilac Sanayive
Ingredient:	furosemide
Patents:	0

Pharmacology for NDA: 215856

Physiological Effect	Increased Diuresis at Loop of Henle

Medical Subject Heading (MeSH) Categories for 215856

Diuretics
Sodium Potassium Chloride Symporter Inhibitors

Suppliers and Packaging for NDA: 215856

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
FUROSEMIDE	furosemide	INJECTABLE;INJECTION	215856	ANDA	Devatis Inc.	73043-022	73043-022-01	25 VIAL, GLASS in 1 BOX (73043-022-01) / 2 mL in 1 VIAL, GLASS
FUROSEMIDE	furosemide	INJECTABLE;INJECTION	215856	ANDA	Devatis Inc.	73043-023	73043-023-01	25 VIAL, GLASS in 1 BOX (73043-023-01) / 4 mL in 1 VIAL, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	10MG/ML
Approval Date:	Apr 2, 2024	TE:	AP	RLD:	No

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