Furosemide

ANDA 70450, held by Watson Labs. Furosemide.

As of Nov 14, 2026, ANDA 70450 (Furosemide), held by Watson Labs, was first approved by FDA on Nov 22, 1985, with 22 approved supplements and 0 published complete response letters.

First approved: Nov 22, 1985
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
Nov 22, 1985	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Furosemide40MG · tablet;oral	Furosemide	Discontinued

All 23 submissions, including labeling and manufacturing supplements


Aug 4, 2005	Supplement 26Labeling	Approved	None posted
Nov 7, 2002	Supplement 25Manufacturing	Approved	None posted
Aug 31, 2001	Supplement 24Manufacturing	Approved	None posted
Nov 10, 1999	Supplement 23Manufacturing	Approved	None posted
Jun 23, 1999	Supplement 21Manufacturing	Approved	None posted
Dec 11, 1998	Supplement 22Labeling	Approved	None posted
Dec 1, 1998	Supplement 20Manufacturing	Approved	None posted
Apr 29, 1996	Supplement 19Labeling	Approved	None posted
Jun 11, 1993	Supplement 18Labeling	Approved	None posted
Apr 8, 1993	Supplement 17Labeling	Approved	None posted
Aug 24, 1992	Supplement 16Labeling	Approved	None posted
Jun 2, 1992	Supplement 15Labeling	Approved	None posted
Jan 10, 1991	Supplement 11Manufacturing	Approved	None posted
Dec 4, 1990	Supplement 14Labeling	Approved	None posted
Aug 2, 1990	Supplement 13Labeling	Approved	None posted
Jun 4, 1990	Supplement 12Labeling	Approved	None posted
May 8, 1990	Supplement 10Manufacturing	Approved	None posted
Nov 4, 1988	Supplement 9Manufacturing	Approved	None posted
Jun 30, 1988	Supplement 8Manufacturing	Approved	None posted
Jun 20, 1988	Supplement 7Manufacturing	Approved	None posted
Jun 24, 1987	Supplement 5Manufacturing	Approved	None posted
Oct 30, 1986	Supplement 1Manufacturing	Approved	None posted
Nov 22, 1985	Original application	Approved	None posted

Identifiers

Application: ANDA 70450
Drugs@FDA: Overview at FDA
Company: Watson Laboratories

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