Nephramine 5.4%

NDA 17766, held by B Braun. Amino Acids.

As of Nov 14, 2026, NDA 17766 (Nephramine 5.4%), held by B Braun, was first approved by FDA on Feb 24, 1978, with 30 approved supplements and 0 published complete response letters.

First approved: Feb 24, 1978
Review: Standard
Supplements approved: 30
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 31 submissions below

Date	Submission	Status	Documents
Feb 24, 1978	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Nephramine 5.4%5.4% (5.4GM/100ML) · injectable;injection	Amino Acids	Discontinued

All 31 submissions, including labeling and manufacturing supplements


Aug 27, 2014	Supplement 41Manufacturing · Standard review	Approved	None posted
Mar 19, 2013	Supplement 36Manufacturing · Standard review	Approved	None posted
May 4, 2006	Supplement 30Labeling · Standard review	Approved	Letter Label
May 5, 2004	Supplement 29Manufacturing · Standard review	Approved	Label Letter
Jun 12, 2002	Supplement 28Labeling · Standard review	Approved	Letter
Jun 14, 1996	Supplement 27Manufacturing · Standard review	Approved	None posted
Oct 28, 1994	Supplement 26Manufacturing · Standard review	Approved	None posted
Jun 8, 1993	Supplement 25Manufacturing · Standard review	Approved	None posted
Sep 28, 1992	Supplement 24Manufacturing · Standard review	Approved	None posted
Dec 18, 1991	Supplement 22Manufacturing · Standard review	Approved	None posted
Dec 11, 1991	Supplement 23Manufacturing · Standard review	Approved	None posted
Apr 11, 1990	Supplement 21Manufacturing · Standard review	Approved	None posted
Apr 11, 1988	Supplement 12Labeling	Approved	None posted
Apr 11, 1988	Supplement 11Manufacturing · Standard review	Approved	None posted
Jan 13, 1988	Supplement 18Labeling	Approved	None posted
Jul 9, 1987	Supplement 17Labeling	Approved	None posted
Oct 9, 1986	Supplement 16Labeling	Approved	None posted
Sep 10, 1985	Supplement 15Labeling	Approved	None posted
Jun 14, 1985	Supplement 13Manufacturing · Standard review	Approved	None posted
Apr 23, 1985	Supplement 14Labeling	Approved	None posted
Oct 8, 1982	Supplement 9Labeling	Approved	None posted
Jun 17, 1982	Supplement 8Manufacturing · Standard review	Approved	None posted
May 18, 1982	Supplement 10Manufacturing · Standard review	Approved	None posted
May 4, 1981	Supplement 7Manufacturing · Standard review	Approved	None posted
Dec 10, 1980	Supplement 6Manufacturing · Standard review	Approved	None posted
Aug 31, 1979	Supplement 5Labeling	Approved	None posted
Aug 31, 1979	Supplement 4Manufacturing · Standard review	Approved	None posted
Jan 5, 1979	Supplement 3Manufacturing · Standard review	Approved	None posted
Jan 4, 1979	Supplement 2Manufacturing · Standard review	Approved	None posted
Jul 11, 1978	Supplement 1Labeling	Approved	None posted
Feb 24, 1978	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 17766
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