Last Updated: August 8, 2026

Details for New Drug Application (NDA): 212803

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NDA 212803 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 212803

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

Pharmacology for NDA: 212803

Physiological Effect	Increased Diuresis at Loop of Henle

Medical Subject Heading (MeSH) Categories for 212803

Diuretics
Sodium Potassium Chloride Symporter Inhibitors

Suppliers and Packaging for NDA: 212803

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
FUROSEMIDE	furosemide	INJECTABLE;INJECTION	212803	ANDA	Meitheal Pharmaceuticals Inc.	71288-203	71288-203-92	25 VIAL, SINGLE-DOSE in 1 CARTON (71288-203-92) / 2 mL in 1 VIAL, SINGLE-DOSE (71288-203-91)
FUROSEMIDE	furosemide	INJECTABLE;INJECTION	212803	ANDA	Meitheal Pharmaceuticals Inc.	71288-203	71288-203-94	25 VIAL, SINGLE-DOSE in 1 CARTON (71288-203-94) / 10 mL in 1 VIAL, SINGLE-DOSE (71288-203-93)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	10MG/ML
Approval Date:	Jan 27, 2022	TE:	AP	RLD:	No

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