Furosemide

Treats edema associated with heart failure, cirrhosis of the liver, and renal disease. NDA 18902, held by Fresenius Kabi USA. Furosemide.

As of Nov 13, 2026, NDA 18902 (Furosemide), held by Fresenius Kabi USA, was first approved by FDA on May 22, 1984, with 20 approved supplements and 0 published complete response letters.

First approved: May 22, 1984
Review: Standard
Supplements approved: 20
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 21 submissions below

Date	Submission	Status	Documents
May 22, 1984	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

1 strengths and forms

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

All 21 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Oct 1, 2024	Supplement 36Labeling · Standard review	Approved	Letter Label
Feb 23, 2023	Supplement 35Labeling · Standard review	Approved	Letter Label
Apr 12, 2022	Supplement 33Labeling · Standard review	Approved	Label Letter
Sep 19, 2016	Supplement 28Labeling · Standard review	Approved	Letter
Mar 8, 2016	Supplement 27Labeling · Standard review	Approved	Label Letter
Jul 1, 2015	Supplement 26Manufacturing · Standard review	Approved	None posted
Mar 27, 2012	Supplement 24Labeling	Approved	None posted
Jan 2, 2001	Supplement 16Manufacturing · Standard review	Approved	None posted
Jan 11, 1999	Supplement 15Manufacturing · Standard review	Approved	None posted
Oct 15, 1997	Supplement 14Labeling	Approved	None posted
Aug 8, 1997	Supplement 13Labeling	Approved	None posted
Apr 22, 1997	Supplement 12Labeling	Approved	None posted
Aug 10, 1995	Supplement 11Labeling	Approved	None posted
Aug 10, 1995	Supplement 10Manufacturing · Standard review	Approved	None posted
Apr 18, 1995	Supplement 7Manufacturing · Standard review	Approved	None posted
Feb 16, 1990	Supplement 8Labeling	Approved	None posted
Jan 11, 1990	Supplement 6Labeling	Approved	None posted
Aug 10, 1988	Supplement 4Manufacturing · Standard review	Approved	None posted
Jul 16, 1986	Supplement 2Manufacturing · Standard review	Approved	None posted
Nov 5, 1985	Supplement 1Manufacturing · Standard review	Approved	None posted
May 22, 1984	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 18902
Drugs@FDA: Overview at FDA
Company: Fresenius Kabi USA

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