Furosemide

NDA 18750, held by Epic Pharma LLC. Furosemide.

As of Nov 13, 2026, NDA 18750 (Furosemide), held by Epic Pharma LLC, was first approved by FDA on Sep 16, 1994, with 1 approved supplement and 0 published complete response letters.

First approved: Sep 16, 1994
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
Sep 16, 1994	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Furosemide40MG · tablet;oral	Furosemide	Discontinued

All 2 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Sep 16, 1994	Original application	Approved	None posted
Aug 23, 1988	Supplement 3Labeling	Approved	None posted

Identifiers

Application: NDA 18750
Drugs@FDA: Overview at FDA
Company: Epic Pharma

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