Trophamine, Trophamine 10%

For extensive burns. NDA 19018, held by B Braun. Amino Acids.

As of Nov 13, 2026, NDA 19018 (Trophamine, Trophamine 10%), held by B Braun, was first approved by FDA on Jul 20, 1984, with 20 approved supplements and 0 published complete response letters.

First approved: Jul 20, 1984
Review: Standard
Supplements approved: 20
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE TrophAmine is indicated for the nutritional support of infants (including those of low birth weight) and young pediatric patients requiring TPN via either central or peripheral infusion routes. Parenteral nutrition with TrophAmine is indicated to prevent nitrogen and weight loss or treat negative nitrogen balance in infants and young pediatric patients where the alimentary tract, by the oral, gastrostomy, or jejunostomy route, cannot or should not be used, or adequate protein intake is not feasible by these routes; gastrointestinal absorption of protein is impaired; or protein requirements are substantially increased as with extensive burns.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 21 submissions below

Date	Submission	Status	Documents
Jul 20, 1984	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

2 strengths and forms


Trophamine6% (6GM/100ML) · injectable;injection	Amino Acids	RxReference drug
Trophamine 10%10% (10GM/100ML) · injectable;injection	Amino Acids	RxReference drug

All 21 submissions, including labeling and manufacturing supplements


Oct 26, 2020	Supplement 36Manufacturing	Approved	Label Letter
Jan 17, 2014	Supplement 32Manufacturing · Standard review	Approved	None posted
Nov 8, 2013	Supplement 31Manufacturing · Standard review	Approved	None posted
Mar 19, 2013	Supplement 26Manufacturing · Standard review	Approved	None posted
Mar 24, 2004	Supplement 18Manufacturing · Standard review	Approved	Label Letter
Jun 20, 2000	Supplement 17Manufacturing · Standard review	Approved	None posted
Apr 11, 2000	Supplement 16Manufacturing · Standard review	Approved	None posted
Apr 23, 1998	Supplement 10Manufacturing · Standard review	Approved	None posted
Jun 14, 1996	Supplement 15Manufacturing · Standard review	Approved	None posted
Oct 28, 1994	Supplement 14Manufacturing · Standard review	Approved	None posted
Sep 28, 1992	Supplement 13Manufacturing · Standard review	Approved	None posted
Dec 11, 1991	Supplement 12Manufacturing · Standard review	Approved	None posted
Apr 11, 1990	Supplement 11Manufacturing · Standard review	Approved	None posted
Dec 19, 1988	Supplement 8Manufacturing · Standard review	Approved	None posted
Sep 7, 1988	Supplement 6Labeling	Approved	None posted
Sep 7, 1988	Supplement 5Manufacturing · Standard review	Approved	None posted
Jan 13, 1988	Supplement 4Labeling	Approved	None posted
Jul 9, 1987	Supplement 3Labeling	Approved	None posted
Oct 9, 1986	Supplement 2Labeling	Approved	None posted
Feb 21, 1985	Supplement 1Labeling	Approved	None posted
Jul 20, 1984	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 19018
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