Furosemide

NDA 18579, held by Am Regent. Furosemide.

As of Nov 14, 2026, NDA 18579 (Furosemide), held by Am Regent, was first approved by FDA on Nov 30, 1983, with 23 approved supplements and 0 published complete response letters.

First approved: Nov 30, 1983
Supplements approved: 23
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 24 submissions below

Date	Submission	Status	Documents
Nov 30, 1983	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Furosemide10MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · injectable;injection	Furosemide	DiscontinuedReference drug

All 24 submissions, including labeling and manufacturing supplements


Oct 1, 2024	Supplement 34Labeling · Standard review	Approved	Letter Label
Mar 30, 2022	Supplement 33Manufacturing	Approved	Label Letter
Jun 27, 2014	Supplement 30Manufacturing	Approved	None posted
Aug 16, 2011	Supplement 29Labeling	Approved	Label
Jul 15, 2002	Supplement 20Manufacturing	Approved	None posted
Jun 27, 2002	Supplement 23Manufacturing	Approved	None posted
Jun 27, 2002	Supplement 22Labeling	Approved	None posted
Jun 27, 2002	Supplement 21Manufacturing	Approved	None posted
Dec 4, 2000	Supplement 19Manufacturing	Approved	None posted
Dec 4, 2000	Supplement 18Manufacturing	Approved	None posted
Dec 4, 2000	Supplement 17Manufacturing	Approved	None posted
Jul 8, 1997	Supplement 15Manufacturing	Approved	None posted
May 21, 1997	Supplement 16Labeling	Approved	None posted
Feb 28, 1996	Supplement 14Manufacturing	Approved	None posted
Jun 7, 1993	Supplement 13Labeling	Approved	None posted
Dec 29, 1992	Supplement 12Manufacturing	Approved	None posted
Apr 14, 1992	Supplement 11Labeling	Approved	None posted
Aug 22, 1991	Supplement 10Labeling	Approved	None posted
Aug 15, 1989	Supplement 9Manufacturing	Approved	None posted
Aug 15, 1989	Supplement 8Manufacturing	Approved	None posted
Aug 15, 1989	Supplement 7Manufacturing	Approved	None posted
Feb 14, 1989	Supplement 4Manufacturing	Approved	None posted
Oct 7, 1988	Supplement 6Labeling	Approved	None posted
Nov 30, 1983	Original application	Approved	None posted

Identifiers

Application: NDA 18579
Drugs@FDA: Overview at FDA
Company: Am Regent

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