Liposyn Iii 10%

NDA 18969, held by Hospira. Soybean Oil.

As of Nov 13, 2026, NDA 18969 (Liposyn Iii 10%), held by Hospira, was first approved by FDA on Sep 24, 1984, with 8 approved supplements and 0 published complete response letters.

First approved: Sep 24, 1984
Review: Standard
Supplements approved: 8
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 9 submissions below

Date	Submission	Status	Documents
Sep 24, 1984	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Liposyn Iii 10%10% · injectable;injection	Soybean Oil	Discontinued

All 9 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Mar 24, 2003	Supplement 12Manufacturing · Standard review	Approved	Letter
Nov 17, 1997	Supplement 9Manufacturing · Standard review	Approved	None posted
Aug 27, 1996	Supplement 8Manufacturing · Standard review	Approved	None posted
Oct 16, 1992	Supplement 7Manufacturing · Standard review	Approved	None posted
Nov 2, 1990	Supplement 6Manufacturing · Standard review	Approved	None posted
Mar 4, 1988	Supplement 5Manufacturing · Standard review	Approved	None posted
Jun 6, 1986	Supplement 2Manufacturing · Standard review	Approved	None posted
Feb 22, 1986	Supplement 3Manufacturing · Standard review	Approved	None posted
Sep 24, 1984	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 18969
Drugs@FDA: Overview at FDA
Company: Hospira

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