Furosemide

ANDA 70082, held by Pharmobedient. Furosemide.

As of Nov 14, 2026, ANDA 70082 (Furosemide), held by Pharmobedient, was first approved by FDA on Oct 29, 1986, with 19 approved supplements and 0 published complete response letters.

First approved: Oct 29, 1986
Supplements approved: 19
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 20 submissions below

Date	Submission	Status	Documents
Oct 29, 1986	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Furosemide80MG · tablet;oral	Furosemide	Discontinued

All 20 submissions, including labeling and manufacturing supplements


Aug 1, 2016	Supplement 28Labeling · Standard review	Approved	None posted
Aug 1, 2016	Supplement 27Labeling · Standard review	Approved	None posted
Nov 4, 2008	Supplement 22Labeling	Approved	None posted
Oct 22, 2001	Supplement 17Manufacturing	Approved	None posted
Oct 22, 2001	Supplement 16Manufacturing	Approved	None posted
Dec 7, 1998	Supplement 15Manufacturing	Approved	None posted
Feb 5, 1998	Supplement 14Manufacturing	Approved	None posted
Oct 6, 1997	Supplement 13Labeling	Approved	None posted
Apr 24, 1996	Supplement 12Labeling	Approved	None posted
Jan 7, 1994	Supplement 11Manufacturing	Approved	None posted
Jun 15, 1993	Supplement 10Labeling	Approved	None posted
Apr 13, 1993	Supplement 8Labeling	Approved	None posted
May 6, 1992	Supplement 7Labeling	Approved	None posted
Mar 18, 1992	Supplement 6Labeling	Approved	None posted
Dec 27, 1990	Supplement 5Labeling	Approved	None posted
May 3, 1990	Supplement 4Labeling	Approved	None posted
Feb 16, 1990	Supplement 2Labeling	Approved	None posted
Jan 31, 1990	Supplement 3Manufacturing	Approved	None posted
Jun 10, 1988	Supplement 1Manufacturing	Approved	None posted
Oct 29, 1986	Original application	Approved	None posted

Identifiers

Application: ANDA 70082
Drugs@FDA: Overview at FDA
Company: PharmoBedient

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