Furosemide

ANDA 71379, held by Ani Pharms. Furosemide.

As of Nov 14, 2026, ANDA 71379 (Furosemide), held by Ani Pharms, was first approved by FDA on Jan 2, 1987, with 20 approved supplements and 0 published complete response letters.

First approved: Jan 2, 1987
Supplements approved: 20
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 21 submissions below

Date	Submission	Status	Documents
Jan 2, 1987	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Furosemide20MG · tablet;oral	Furosemide	Discontinued

All 21 submissions, including labeling and manufacturing supplements


Nov 7, 2002	Supplement 20Manufacturing	Approved	None posted
Aug 31, 2001	Supplement 19Manufacturing	Approved	None posted
Nov 10, 1999	Supplement 18Manufacturing	Approved	None posted
Jun 23, 1999	Supplement 16Manufacturing	Approved	None posted
Dec 11, 1998	Supplement 17Labeling	Approved	None posted
Apr 29, 1996	Supplement 15Labeling	Approved	None posted
Jun 11, 1993	Supplement 14Labeling	Approved	None posted
Apr 8, 1993	Supplement 13Labeling	Approved	None posted
Aug 24, 1992	Supplement 12Labeling	Approved	None posted
Jun 2, 1992	Supplement 11Labeling	Approved	None posted
Dec 4, 1990	Supplement 10Labeling	Approved	None posted
Aug 2, 1990	Supplement 9Labeling	Approved	None posted
May 8, 1990	Supplement 7Manufacturing	Approved	None posted
May 8, 1990	Supplement 6Manufacturing	Approved	None posted
Apr 12, 1990	Supplement 8Labeling	Approved	None posted
Nov 4, 1988	Supplement 5Manufacturing	Approved	None posted
Jun 20, 1988	Supplement 4Manufacturing	Approved	None posted
Jun 20, 1988	Supplement 3Manufacturing	Approved	None posted
Jun 20, 1988	Supplement 2Manufacturing	Approved	None posted
Sep 10, 1987	Supplement 1Manufacturing	Approved	None posted
Jan 2, 1987	Original application	Approved	None posted

Identifiers

Application: ANDA 71379
Drugs@FDA: Overview at FDA
Company: ANI Pharmaceuticals

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