Hepatamine 8%

NDA 18676, held by B Braun. Amino Acids.

As of Nov 13, 2026, NDA 18676 (Hepatamine 8%), held by B Braun, was first approved by FDA on Aug 3, 1982, with 22 approved supplements and 0 published complete response letters.

First approved: Aug 3, 1982
Review: Standard
Supplements approved: 22
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 23 submissions below

Date	Submission	Status	Documents
Aug 3, 1982	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Hepatamine 8%8% (8GM/100ML) · injectable;injection	Amino Acids	Discontinued

All 23 submissions, including labeling and manufacturing supplements


Nov 17, 2014	Supplement 32Manufacturing · Standard review	Approved	None posted
Mar 19, 2013	Supplement 27Manufacturing · Standard review	Approved	None posted
Apr 29, 2004	Supplement 22Manufacturing · Standard review	Approved	Label Letter
Jun 20, 2000	Supplement 21Manufacturing · Standard review	Approved	None posted
Apr 11, 2000	Supplement 20Manufacturing · Standard review	Approved	None posted
Jun 14, 1996	Supplement 19Manufacturing · Standard review	Approved	None posted
Oct 28, 1994	Supplement 18Manufacturing · Standard review	Approved	None posted
Jun 8, 1993	Supplement 17Manufacturing · Standard review	Approved	None posted
Sep 28, 1992	Supplement 16Manufacturing · Standard review	Approved	None posted
Dec 11, 1991	Supplement 15Manufacturing · Standard review	Approved	None posted
Apr 11, 1990	Supplement 14Manufacturing · Standard review	Approved	None posted
Apr 11, 1988	Supplement 4Labeling	Approved	None posted
Mar 11, 1988	Supplement 3Manufacturing · Standard review	Approved	None posted
Jan 13, 1988	Supplement 11Labeling	Approved	None posted
Jul 9, 1987	Supplement 10Labeling	Approved	None posted
Nov 13, 1986	Supplement 9Manufacturing · Standard review	Approved	None posted
Oct 3, 1986	Supplement 8Labeling	Approved	None posted
Oct 3, 1986	Supplement 5Manufacturing · Standard review	Approved	None posted
Jul 16, 1985	Supplement 7Labeling	Approved	None posted
Apr 10, 1985	Supplement 6Manufacturing · Standard review	Approved	None posted
Dec 13, 1982	Supplement 2Labeling	Approved	None posted
Oct 15, 1982	Supplement 1Manufacturing · Standard review	Approved	None posted
Aug 3, 1982	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 18676
Drugs@FDA: Overview at FDA
Company: B. Braun Medical

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