Furosemide

As of Nov 13, 2026, ANDA 77941 (Furosemide), held by Apotex, was first approved by FDA on Mar 22, 2007, with 1 approved supplement and 0 published complete response letters.

First approved: Mar 22, 2007
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Mar 22, 2007	Original application	Approved	None posted

Products

1 strengths and forms

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

All 2 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Oct 19, 2021	Supplement 1Labeling · Standard review	Approved	None posted
Mar 22, 2007	Original application	Approved	None posted

Identifiers

Application: ANDA 77941
Drugs@FDA: Overview at FDA
Company: Apotex

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