Liposyn Ii 20%

NDA 18991, held by Hospira. Safflower Oil; Soybean Oil.

As of Nov 13, 2026, NDA 18991 (Liposyn Ii 20%), held by Hospira, was first approved by FDA on Aug 27, 1984, with 19 approved supplements and 0 published complete response letters.

First approved: Aug 27, 1984
Review: Standard
Supplements approved: 19
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 20 submissions below

Date	Submission	Status	Documents
Aug 27, 1984	Original applicationNew combination · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Liposyn Ii 20%10%;10% (10GM/100ML) · injectable;injection	Safflower Oil; Soybean Oil	Discontinued

All 20 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Apr 14, 2003	Supplement 25Manufacturing · Standard review	Approved	Letter
Feb 15, 2001	Supplement 17Labeling	Approved	None posted
Nov 17, 1997	Supplement 22Manufacturing · Standard review	Approved	None posted
Aug 29, 1996	Supplement 21Manufacturing · Standard review	Approved	None posted
Aug 27, 1996	Supplement 19Manufacturing · Standard review	Approved	None posted
Sep 22, 1994	Supplement 18Manufacturing · Standard review	Approved	None posted
Jan 4, 1991	Supplement 15Manufacturing · Standard review	Approved	None posted
Nov 2, 1990	Supplement 16Manufacturing · Standard review	Approved	None posted
Oct 24, 1989	Supplement 14Manufacturing · Standard review	Approved	None posted
Jul 20, 1989	Supplement 13Labeling	Approved	None posted
Mar 4, 1988	Supplement 11Manufacturing · Standard review	Approved	None posted
Jun 6, 1986	Supplement 7Manufacturing · Standard review	Approved	None posted
Apr 2, 1986	Supplement 5Manufacturing · Standard review	Approved	None posted
Apr 1, 1986	Supplement 8Labeling	Approved	None posted
Feb 22, 1986	Supplement 9Manufacturing · Standard review	Approved	None posted
Oct 3, 1985	Supplement 2Labeling	Approved	None posted
Oct 3, 1985	Supplement 1Manufacturing · Standard review	Approved	None posted
Sep 12, 1985	Supplement 4Manufacturing · Standard review	Approved	None posted
Jan 26, 1985	Supplement 3Manufacturing · Standard review	Approved	None posted
Aug 27, 1984	Original applicationNew combination · Standard review	Approved	None posted

Identifiers

Application: NDA 18991
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