Furosemide

ANDA 70100, held by Sun Pharm Industries. Furosemide.

As of Nov 13, 2026, ANDA 70100 (Furosemide), held by Sun Pharm Industries, was first approved by FDA on Jan 26, 1988, with 10 approved supplements and 0 published complete response letters.

First approved: Jan 26, 1988
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
Jan 26, 1988	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Furosemide80MG · tablet;oral	Furosemide	Discontinued

All 11 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Dec 1, 1998	Supplement 11Manufacturing	Approved	None posted
Dec 23, 1994	Supplement 10Manufacturing	Approved	None posted
Oct 11, 1994	Supplement 9Manufacturing	Approved	None posted
Aug 17, 1993	Supplement 8Labeling	Approved	None posted
Aug 11, 1992	Supplement 7Labeling	Approved	None posted
May 1, 1992	Supplement 6Labeling	Approved	None posted
Apr 3, 1992	Supplement 3Manufacturing	Approved	None posted
Apr 3, 1992	Supplement 5Manufacturing	Approved	None posted
Apr 2, 1991	Supplement 2Labeling	Approved	None posted
Aug 24, 1988	Supplement 1Manufacturing	Approved	None posted
Jan 26, 1988	Original application	Approved	None posted

Identifiers

Application: ANDA 70100
Drugs@FDA: Overview at FDA
Company: Sun Pharmaceutical Industries

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