Furosemide

ANDA 70043, held by Sun Pharm Industries. Furosemide.

As of Nov 14, 2026, ANDA 70043 (Furosemide), held by Sun Pharm Industries, was first approved by FDA on Sep 26, 1985, with 15 approved supplements and 0 published complete response letters.

First approved: Sep 26, 1985
Supplements approved: 15
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 16 submissions below

Date	Submission	Status	Documents
Sep 26, 1985	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Furosemide20MG · tablet;oral	Furosemide	Discontinued

All 16 submissions, including labeling and manufacturing supplements


Dec 1, 1998	Supplement 22Manufacturing	Approved	None posted
Dec 23, 1994	Supplement 21Manufacturing	Approved	None posted
Oct 11, 1994	Supplement 20Manufacturing	Approved	None posted
Aug 17, 1993	Supplement 19Labeling	Approved	None posted
Aug 11, 1992	Supplement 18Labeling	Approved	None posted
May 1, 1992	Supplement 17Labeling	Approved	None posted
Apr 3, 1992	Supplement 16Manufacturing	Approved	None posted
Apr 3, 1992	Supplement 14Manufacturing	Approved	None posted
Apr 2, 1991	Supplement 13Labeling	Approved	None posted
Aug 24, 1988	Supplement 11Manufacturing	Approved	None posted
Dec 14, 1987	Supplement 9Manufacturing	Approved	None posted
Jul 24, 1986	Supplement 4Manufacturing	Approved	None posted
Jul 24, 1986	Supplement 3Manufacturing	Approved	None posted
Jul 24, 1986	Supplement 2Manufacturing	Approved	None posted
Jan 2, 1986	Supplement 1Manufacturing	Approved	None posted
Sep 26, 1985	Original application	Approved	None posted

Identifiers

Application: ANDA 70043
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