Furosemide

NDA 18790, held by Sun Pharm Inds Inc. Furosemide.

As of Nov 13, 2026, NDA 18790 (Furosemide), held by Sun Pharm Inds Inc, was first approved by FDA on Oct 6, 1983, with 25 approved supplements and 0 published complete response letters.

First approved: Oct 6, 1983
Supplements approved: 25
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 26 submissions below

Date	Submission	Status	Documents
Oct 6, 1983	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Furosemide40MG · tablet;oral	Furosemide	Discontinued

All 26 submissions, including labeling and manufacturing supplements


Dec 1, 1998	Supplement 37Manufacturing	Approved	None posted
Dec 23, 1994	Supplement 36Manufacturing	Approved	None posted
Oct 11, 1994	Supplement 35Manufacturing	Approved	None posted
Aug 17, 1993	Supplement 34Labeling	Approved	None posted
Aug 11, 1992	Supplement 33Labeling	Approved	None posted
May 1, 1992	Supplement 32Labeling	Approved	None posted
Apr 3, 1992	Supplement 31Manufacturing	Approved	None posted
Apr 3, 1992	Supplement 29Manufacturing	Approved	None posted
Apr 2, 1991	Supplement 28Labeling	Approved	None posted
Feb 5, 1991	Supplement 27Manufacturing	Approved	None posted
Feb 5, 1991	Supplement 25Manufacturing	Approved	None posted
May 10, 1989	Supplement 26Labeling	Approved	None posted
Feb 24, 1989	Supplement 23Manufacturing	Approved	None posted
Feb 24, 1989	Supplement 22Manufacturing	Approved	None posted
Feb 24, 1989	Supplement 21Manufacturing	Approved	None posted
Dec 22, 1988	Supplement 24Labeling	Approved	None posted
Feb 24, 1988	Supplement 17Manufacturing	Approved	None posted
Dec 10, 1987	Supplement 19Manufacturing	Approved	None posted
Jul 27, 1987	Supplement 18Manufacturing	Approved	None posted
Dec 12, 1986	Supplement 14Manufacturing	Approved	None posted
Dec 12, 1986	Supplement 13Manufacturing	Approved	None posted
Jan 7, 1986	Supplement 12Manufacturing	Approved	None posted
Oct 21, 1985	Supplement 11Manufacturing	Approved	None posted
Jun 28, 1985	Supplement 10Manufacturing	Approved	None posted
Jun 28, 1985	Supplement 9Manufacturing	Approved	None posted
Oct 6, 1983	Original application	Approved	None posted

Identifiers

Application: NDA 18790
Drugs@FDA: Overview at FDA
Company: Sun Pharmaceutical Industries

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