Lasix

NDA 17688, held by Sanofi Aventis US. Furosemide.

As of Nov 13, 2026, NDA 17688 (Lasix), held by Sanofi Aventis US, was first approved by FDA on Mar 8, 1977, with 22 approved supplements and 0 published complete response letters.

First approved: Mar 8, 1977
Review: Standard
Supplements approved: 22
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 23 submissions below

Date	Submission	Status	Documents
Mar 8, 1977	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Lasix10MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · solution;oral	Furosemide	DiscontinuedReference drug

All 23 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Jun 24, 1996	Supplement 22Manufacturing · Standard review	Approved	None posted
May 1, 1995	Supplement 21Manufacturing · Standard review	Approved	None posted
Jan 26, 1995	Supplement 18Labeling	Approved	None posted
Dec 7, 1994	Supplement 20Manufacturing · Standard review	Approved	None posted
Aug 26, 1993	Supplement 19Manufacturing · Standard review	Approved	None posted
Nov 13, 1992	Supplement 17Labeling	Approved	None posted
Jun 9, 1992	Supplement 16Manufacturing · Standard review	Approved	None posted
Dec 19, 1991	Supplement 11Manufacturing · Standard review	Approved	None posted
Nov 7, 1991	Supplement 15Manufacturing · Standard review	Approved	None posted
Oct 23, 1991	Supplement 13Labeling	Approved	None posted
May 23, 1991	Supplement 14Manufacturing · Standard review	Approved	None posted
Nov 9, 1990	Supplement 12Manufacturing · Standard review	Approved	None posted
May 18, 1990	Supplement 10Manufacturing · Standard review	Approved	None posted
Mar 15, 1990	Supplement 6Labeling	Approved	None posted
Mar 15, 1990	Supplement 9Labeling	Approved	None posted
May 29, 1984	Supplement 8Manufacturing · Standard review	Approved	None posted
Aug 23, 1982	Supplement 7Manufacturing · Standard review	Approved	None posted
Jan 9, 1981	Supplement 5Labeling	Approved	None posted
Jul 10, 1979	Supplement 4Labeling	Approved	None posted
Apr 14, 1978	Supplement 1Labeling	Approved	None posted
Apr 14, 1978	Supplement 2Labeling	Approved	None posted
Apr 14, 1978	Supplement 3Labeling	Approved	None posted
Mar 8, 1977	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 17688
Drugs@FDA: Overview at FDA
Company: sanofi-aventis US

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