Last Updated: September 24, 2026

Details for New Drug Application (NDA): 207552

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NDA 207552 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 is one drug master file entry for this compound. Sixty-three suppliers are listed for this compound. Additional details are available on the furosemide profile page.

Summary for 207552

Tradename:	FUROSEMIDE
Applicant:	Amneal Pharms Co
Ingredient:	furosemide
Patents:	0

Pharmacology for NDA: 207552

Physiological Effect	Increased Diuresis at Loop of Henle

Medical Subject Heading (MeSH) Categories for 207552

Diuretics
Sodium Potassium Chloride Symporter Inhibitors

Suppliers and Packaging for NDA: 207552

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
FUROSEMIDE	furosemide	INJECTABLE;INJECTION	207552	ANDA	Amneal Pharmaceuticals LLC	70121-1163	70121-1163-5	25 VIAL, GLASS in 1 CARTON (70121-1163-5) / 2 mL in 1 VIAL, GLASS (70121-1163-1)
FUROSEMIDE	furosemide	INJECTABLE;INJECTION	207552	ANDA	Amneal Pharmaceuticals LLC	70121-1164	70121-1164-5	25 VIAL, GLASS in 1 CARTON (70121-1164-5) / 4 mL in 1 VIAL, GLASS (70121-1164-1)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	10MG/ML
Approval Date:	Jul 20, 2016	TE:		RLD:	No

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