Neopham 6.4%

NDA 18792, held by Hospira. Amino Acids.

As of Nov 13, 2026, NDA 18792 (Neopham 6.4%), held by Hospira, was first approved by FDA on Jan 17, 1984, with 10 approved supplements and 0 published complete response letters.

First approved: Jan 17, 1984
Review: Standard
Supplements approved: 10
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 11 submissions below

Date	Submission	Status	Documents
Jan 17, 1984	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Neopham 6.4%6.4% (6.4GM/100ML) · injectable;injection	Amino Acids	Discontinued

All 11 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Feb 9, 1995	Supplement 13Manufacturing · Standard review	Approved	None posted
Mar 30, 1994	Supplement 11Manufacturing · Standard review	Approved	None posted
Jan 11, 1993	Supplement 12Manufacturing · Standard review	Approved	None posted
Apr 5, 1990	Supplement 9Manufacturing · Standard review	Approved	None posted
Apr 5, 1990	Supplement 10Manufacturing · Standard review	Approved	None posted
Apr 10, 1989	Supplement 8Manufacturing · Standard review	Approved	None posted
Dec 11, 1986	Supplement 6Labeling · Standard review	Approved	None posted
Dec 11, 1986	Supplement 7Manufacturing · Standard review	Approved	None posted
Jun 19, 1985	Supplement 1Manufacturing · Standard review	Approved	None posted
Jul 27, 1984	Supplement 5Manufacturing · Standard review	Approved	None posted
Jan 17, 1984	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 18792
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