Aminohippurate Sodium

NDA 5619, held by Merck. Aminohippurate Sodium.

As of Nov 14, 2026, NDA 5619 (Aminohippurate Sodium), held by Merck, was first approved by FDA on Dec 30, 1944, with 19 approved supplements and 0 published complete response letters.

First approved: Dec 30, 1944
Supplements approved: 19
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 20 submissions below

Date	Submission	Status	Documents
Dec 30, 1944	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Aminohippurate Sodium20% · injectable;injection	Aminohippurate Sodium	Discontinued

All 20 submissions, including labeling and manufacturing supplements


Oct 24, 2013	Supplement 24Manufacturing	Approved	None posted
Jun 7, 2013	Supplement 23Manufacturing	Approved	None posted
Mar 18, 2011	Supplement 21Labeling	Approved	Letter Label
Jun 3, 2005	Supplement 20Labeling · Standard review	Approved	Letter
Nov 26, 2002	Supplement 18Labeling · Standard review	Approved	Letter
Oct 8, 2002	Supplement 17Manufacturing	Approved	None posted
Mar 30, 2001	Supplement 16Manufacturing	Approved	Letter
Nov 2, 1999	Supplement 15Labeling · Standard review	Approved	None posted
Jan 5, 1998	Supplement 14Manufacturing	Approved	None posted
Mar 11, 1996	Supplement 13Manufacturing	Approved	None posted
Feb 13, 1987	Supplement 12Labeling	Approved	None posted
Feb 13, 1987	Supplement 10Labeling	Approved	None posted
Feb 13, 1987	Supplement 9Manufacturing	Approved	None posted
Sep 1, 1982	Supplement 11Manufacturing	Approved	None posted
Oct 8, 1981	Supplement 7Manufacturing	Approved	None posted
Jun 23, 1981	Supplement 8Manufacturing	Approved	None posted
Apr 7, 1977	Supplement 6Labeling	Approved	None posted
Aug 10, 1973	Supplement 2Manufacturing	Approved	None posted
Aug 10, 1973	Supplement 1Labeling	Approved	None posted
Dec 30, 1944	Original application	Approved	None posted

Identifiers

Application: NDA 5619
Drugs@FDA: Overview at FDA
Company: Merck & Co. (MSD)

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