Furosemide

ANDA 70412, held by Watson Labs. Furosemide.

As of Nov 14, 2026, ANDA 70412 (Furosemide), held by Watson Labs, was first approved by FDA on Feb 26, 1986, with 10 approved supplements and 0 published complete response letters.

First approved: Feb 26, 1986
Supplements approved: 10
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 11 submissions below

Date	Submission	Status	Documents
Feb 26, 1986	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Furosemide20MG · tablet;oral	Furosemide	Discontinued

All 11 submissions, including labeling and manufacturing supplements


Apr 7, 1993	Supplement 12Labeling	Approved	None posted
Jan 13, 1993	Supplement 11Labeling	Approved	None posted
May 31, 1991	Supplement 7Manufacturing	Approved	None posted
May 17, 1991	Supplement 9Labeling	Approved	None posted
Nov 19, 1990	Supplement 8Manufacturing	Approved	None posted
Jun 29, 1990	Supplement 6Manufacturing	Approved	None posted
Jul 12, 1988	Supplement 3Manufacturing	Approved	None posted
Jul 12, 1988	Supplement 4Manufacturing	Approved	None posted
Jul 12, 1988	Supplement 5Manufacturing	Approved	None posted
Jun 7, 1988	Supplement 2Manufacturing	Approved	None posted
Feb 26, 1986	Original application	Approved	None posted

Identifiers

Application: ANDA 70412
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