Aminosyn-Pf 7%

For extensive burns. NDA 19398, held by Otsuka Icu Medcl. Amino Acids.

As of Nov 13, 2026, NDA 19398 (Aminosyn-Pf 7%), held by Otsuka Icu Medcl, was first approved by FDA on Sep 6, 1985, with 16 approved supplements and 0 published complete response letters.

First approved: Sep 6, 1985
Review: Standard
Supplements approved: 16
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Aminosyn-PF 7%, Sulfite-Free, (an amino acid injection — pediatric formula) is indicated for the nutritional support of infants (including those of low birth weight) and young children requiring TPN via either central or peripheral infusion routes.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 17 submissions below

Date	Submission	Status	Documents
Sep 6, 1985	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Aminosyn-Pf 7%7% (7GM/100ML) · injectable;injection	Amino Acids	Rx

All 17 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
May 24, 2016	Supplement 37Manufacturing · Standard review	Approved	None posted
Jan 19, 2016	Supplement 36Manufacturing · Standard review	Approved	None posted
Oct 25, 2002	Supplement 16Manufacturing · Standard review	Approved	Letter
Sep 11, 2002	Supplement 15Manufacturing · Standard review	Approved	None posted
Jun 8, 1999	Supplement 14Manufacturing · Standard review	Approved	None posted
May 5, 1997	Supplement 13Manufacturing · Standard review	Approved	None posted
Aug 27, 1996	Supplement 12Manufacturing · Standard review	Approved	None posted
Jul 11, 1994	Supplement 11Manufacturing · Standard review	Approved	None posted
Dec 30, 1993	Supplement 10Manufacturing · Standard review	Approved	None posted
Sep 28, 1992	Supplement 9Manufacturing · Standard review	Approved	None posted
Aug 18, 1992	Supplement 8Manufacturing · Standard review	Approved	None posted
Feb 10, 1992	Supplement 7Manufacturing · Standard review	Approved	None posted
Aug 17, 1987	Supplement 6Labeling	Approved	None posted
Dec 15, 1986	Supplement 5Labeling	Approved	None posted
Dec 15, 1986	Supplement 4Manufacturing · Standard review	Approved	None posted
Jan 31, 1986	Supplement 1Manufacturing · Standard review	Approved	None posted
Sep 6, 1985	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 19398
Drugs@FDA: Overview at FDA
Company: Otsuka ICU 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