Furosemide

Treats edema associated with heart failure, cirrhosis of the liver, and renal disease. NDA 18667, held by Hospira. Furosemide.

As of Nov 13, 2026, NDA 18667 (Furosemide), held by Hospira, was first approved by FDA on May 28, 1982, with 18 approved supplements and 0 published complete response letters.

First approved: May 28, 1982
Supplements approved: 18
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

FUROSEMIDE INJECTION is a loop diuretic indicated for:

The treatment of edema associated with heart failure, cirrhosis of the liver, and renal disease
Acute pulmonary edema as adjunctive therapy 1.1 Edema Furosemide Injection is indicated in adults and pediatric patients for the treatment of edema associated with heart failure, cirrhosis of the liver, and renal disease, including the nephrotic syndrome. 1.2 Acute Pulmonary Edema Furosemide Injection is indicated as adjunctive therapy in acute pulmonary edema.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 19 submissions below

Date	Submission	Status	Documents
May 28, 1982	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Furosemide10MG/ML · injectable;injection	Furosemide	Rx

All 19 submissions, including labeling and manufacturing supplements


Oct 1, 2024	Supplement 48Labeling · Standard review	Approved	Letter Label
Aug 31, 2022	Supplement 43Labeling · Standard review	Approved	Letter Label
Sep 22, 2016	Supplement 36Labeling · Standard review	Approved	Letter Label
May 10, 2012	Supplement 34Labeling · Standard review	Approved	None posted
Oct 25, 2002	Supplement 19Manufacturing	Approved	None posted
Mar 22, 2001	Supplement 18Manufacturing	Approved	None posted
Mar 22, 2001	Supplement 17Manufacturing	Approved	None posted
Jan 7, 2000	Supplement 16Labeling	Approved	None posted
Jan 7, 2000	Supplement 15Manufacturing	Approved	None posted
May 12, 1997	Supplement 14Labeling	Approved	None posted
Oct 3, 1996	Supplement 13Manufacturing	Approved	None posted
Jan 27, 1994	Supplement 9Labeling	Approved	None posted
Mar 9, 1993	Supplement 8Labeling	Approved	None posted
Jul 9, 1992	Supplement 7Labeling	Approved	None posted
Jun 16, 1988	Supplement 6Labeling	Approved	None posted
Jan 20, 1988	Supplement 5Manufacturing	Approved	None posted
Jan 20, 1988	Supplement 3Manufacturing	Approved	None posted
Jan 20, 1988	Supplement 1Manufacturing	Approved	None posted
May 28, 1982	Original application	Approved	None posted

Identifiers

Application: NDA 18667
Drugs@FDA: Overview at FDA
Company: Hospira

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters