Furosemide

ANDA 70449, held by Watson Labs Teva. Furosemide.

As of Nov 13, 2026, ANDA 70449 (Furosemide), held by Watson Labs Teva, was first approved by FDA on Nov 22, 1985, with 23 approved supplements and 0 published complete response letters.

First approved: Nov 22, 1985
Supplements approved: 23
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 24 submissions below

Date	Submission	Status	Documents
Nov 22, 1985	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Furosemide20MG · tablet;oral	Furosemide	Discontinued

All 24 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
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
Apr 29, 1996	Supplement 20Labeling	Approved	None posted
Jun 11, 1993	Supplement 19Labeling	Approved	None posted
Apr 8, 1993	Supplement 18Labeling	Approved	None posted
Aug 24, 1992	Supplement 17Labeling	Approved	None posted
Jun 2, 1992	Supplement 16Labeling	Approved	None posted
Jan 10, 1991	Supplement 12Manufacturing	Approved	None posted
Dec 4, 1990	Supplement 15Labeling	Approved	None posted
Aug 2, 1990	Supplement 14Labeling	Approved	None posted
Jun 4, 1990	Supplement 13Labeling	Approved	None posted
May 8, 1990	Supplement 11Manufacturing	Approved	None posted
Nov 4, 1988	Supplement 10Manufacturing	Approved	None posted
Jun 17, 1988	Supplement 7Manufacturing	Approved	None posted
Jun 17, 1988	Supplement 8Manufacturing	Approved	None posted
Jun 17, 1988	Supplement 9Manufacturing	Approved	None posted
Jun 24, 1987	Supplement 6Manufacturing	Approved	None posted
Oct 30, 1986	Supplement 1Manufacturing	Approved	None posted
Oct 30, 1986	Supplement 4Manufacturing	Approved	None posted
Nov 22, 1985	Original application	Approved	None posted

Identifiers

Application: ANDA 70449
Drugs@FDA: Overview at FDA
Company: Watson Labs Teva

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters