Furosemide

ANDA 75241, held by Hospira. Furosemide.

As of Nov 13, 2026, ANDA 75241 (Furosemide), held by Hospira, was first approved by FDA on May 28, 1999, with 4 approved supplements and 0 published complete response letters.

First approved: May 28, 1999
Supplements approved: 4
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
May 28, 1999	Original application	Approved	Review Letter Label

Products

1 strengths and forms

Product	Active ingredient	Marketing
Furosemide10MG/ML · injectable;injection	Furosemide	Rx

All 5 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Sep 12, 2025	Supplement 23Labeling · Standard review	Approved	None posted
Dec 5, 2022	Supplement 15Labeling · Standard review	Approved	None posted
Dec 5, 2022	Supplement 16Labeling · Standard review	Approved	None posted
May 10, 2012	Supplement 12Labeling · Standard review	Approved	None posted
May 28, 1999	Original application	Approved	Review Letter Label

Identifiers

Application: ANDA 75241
Drugs@FDA: Overview at FDA
Company: Hospira

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