Furosemide

Treats edema associated with congestive heart failure, cirrhosis … the nephrotic syndrome. ANDA 70086, held by Hikma. Furosemide.

As of Nov 14, 2026, ANDA 70086 (Furosemide), held by Hikma, was first approved by FDA on Jan 24, 1986, with 31 approved supplements and 0 published complete response letters.

First approved: Jan 24, 1986
Supplements approved: 31
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Edema Furosemide is indicated in adults and pediatric patients for the treatment of edema associated with congestive heart failure, cirrhosis of the liver and renal disease, including the nephrotic syndrome. Furosemide is particularly useful when an agent with greater diuretic potential is desired. Hypertension Oral furosemide may be used in adults for the treatment of hypertension alone or in combination with other antihypertensive agents. Hypertensive patients who cannot be adequately controlled with thiazides will probably also not be adequately controlled with furosemide alone.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 32 submissions below

Date	Submission	Status	Documents
Jan 24, 1986	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Furosemide80MG · tablet;oral	Furosemide	Rx

All 32 submissions, including labeling and manufacturing supplements


Nov 5, 2020	Supplement 43Labeling · Standard review	Approved	None posted
Nov 5, 2020	Supplement 40Labeling · Standard review	Approved	None posted
May 10, 2012	Supplement 38Labeling	Approved	None posted
Jan 26, 2011	Supplement 36Labeling	Approved	None posted
May 4, 2009	Supplement 35Labeling	Approved	None posted
Mar 28, 2007	Supplement 34Labeling	Approved	None posted
May 23, 2002	Supplement 30Manufacturing	Approved	None posted
May 7, 2002	Supplement 29Manufacturing	Approved	None posted
May 7, 2002	Supplement 28Manufacturing	Approved	None posted
May 7, 2002	Supplement 27Manufacturing	Approved	None posted
Aug 30, 2001	Supplement 26Manufacturing	Approved	None posted
Aug 30, 2001	Supplement 25Manufacturing	Approved	None posted
Sep 10, 1998	Supplement 24Manufacturing	Approved	None posted
Apr 22, 1997	Supplement 23Labeling	Approved	None posted
Aug 28, 1996	Supplement 22Manufacturing	Approved	None posted
Apr 13, 1995	Supplement 21Labeling	Approved	None posted
Jun 24, 1994	Supplement 20Labeling	Approved	None posted
Aug 28, 1992	Supplement 19Labeling	Approved	None posted
Nov 18, 1991	Supplement 17Manufacturing	Approved	None posted
May 3, 1991	Supplement 16Manufacturing	Approved	None posted
May 3, 1991	Supplement 12Manufacturing	Approved	None posted
Mar 13, 1991	Supplement 14Manufacturing	Approved	None posted
Mar 13, 1991	Supplement 3Labeling	Approved	None posted
Mar 13, 1991	Supplement 2Manufacturing	Approved	None posted
Dec 18, 1990	Supplement 15Labeling	Approved	None posted
Dec 28, 1989	Supplement 13Labeling	Approved	None posted
Apr 19, 1989	Supplement 9Labeling	Approved	None posted
Sep 13, 1988	Supplement 11Manufacturing	Approved	None posted
Jul 12, 1988	Supplement 6Manufacturing	Approved	None posted
May 6, 1988	Supplement 7Labeling	Approved	None posted
Jan 24, 1986	Original application	Approved	None posted
May 13, 1985	Supplement 1Manufacturing	Approved	None posted

Identifiers

Application: ANDA 70086
Drugs@FDA: Overview at FDA
Company: Hikma

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