Edecrin

NDA 16093, held by Bausch. Ethacrynate Sodium.

As of Nov 14, 2026, NDA 16093 (Edecrin), held by Bausch, was first approved by FDA on Jan 10, 1967, with 35 approved supplements and 0 published complete response letters.

First approved: Jan 10, 1967
Review: Standard
Supplements approved: 35
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 36 submissions below

Date	Submission	Status	Documents
Jan 10, 1967	Original applicationNew active ingredient · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
EdecrinEQ 50MG BASE/VIAL · injectable;injection	Ethacrynate Sodium	RxReference drug

All 36 submissions, including labeling and manufacturing supplements


Jul 20, 2005	Supplement 45Manufacturing · Standard review	Approved	None posted
Feb 9, 2005	Supplement 44Labeling · Standard review	Approved	Letter Label
Feb 3, 2004	Supplement 43Labeling · Standard review	Approved	Letter
Jun 10, 2002	Supplement 42Manufacturing · Standard review	Approved	None posted
Jul 19, 2001	Supplement 41Manufacturing · Standard review	Approved	None posted
Jun 18, 2001	Supplement 40Manufacturing · Standard review	Approved	None posted
Feb 14, 2001	Supplement 39Manufacturing · Standard review	Approved	None posted
Oct 19, 1999	Supplement 38Labeling · Standard review	Approved	Review
Sep 3, 1999	Supplement 37Manufacturing · Standard review	Approved	None posted
Nov 3, 1997	Supplement 36Labeling · Standard review	Approved	None posted
Oct 8, 1996	Supplement 33Manufacturing · Standard review	Approved	None posted
Nov 30, 1995	Supplement 35Manufacturing · Standard review	Approved	None posted
Mar 24, 1995	Supplement 34Labeling · Standard review	Approved	None posted
Aug 7, 1991	Supplement 32Manufacturing · Standard review	Approved	None posted
May 30, 1989	Supplement 31Manufacturing · Standard review	Approved	None posted
Dec 8, 1986	Supplement 30Manufacturing · Standard review	Approved	None posted
Mar 21, 1986	Supplement 29Labeling	Approved	None posted
Jan 13, 1986	Supplement 28Labeling	Approved	None posted
Aug 27, 1985	Supplement 27Manufacturing · Standard review	Approved	None posted
May 13, 1985	Supplement 20Labeling	Approved	None posted
Oct 11, 1984	Supplement 26Manufacturing · Standard review	Approved	None posted
Aug 28, 1984	Supplement 25Labeling	Approved	None posted
Sep 20, 1983	Supplement 24Manufacturing · Standard review	Approved	None posted
May 19, 1983	Supplement 23Manufacturing · Standard review	Approved	None posted
Nov 3, 1981	Supplement 21Manufacturing · Standard review	Approved	None posted
Aug 28, 1981	Supplement 19Manufacturing · Standard review	Approved	None posted
Jul 14, 1981	Supplement 22Manufacturing · Standard review	Approved	None posted
Feb 19, 1981	Supplement 17Manufacturing · Standard review	Approved	None posted
Jan 16, 1981	Supplement 18Labeling	Approved	None posted
Jan 25, 1980	Supplement 16Labeling	Approved	None posted
Jun 21, 1979	Supplement 15Manufacturing · Standard review	Approved	None posted
Aug 28, 1978	Supplement 14Manufacturing · Standard review	Approved	None posted
Aug 28, 1978	Supplement 11Manufacturing · Standard review	Approved	None posted
Mar 10, 1978	Supplement 13Labeling	Approved	None posted
Jan 29, 1976	Supplement 12Manufacturing · Standard review	Approved	None posted
Jan 10, 1967	Original applicationNew active ingredient · Standard review	Approved	None posted

Identifiers

Application: NDA 16093
Drugs@FDA: Overview at FDA
Company: Bausch Health

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