Veinamine 8%, Novamine 8.5%, Novamine 11.4%

NDA 17957, held by Hospira Inc. Amino Acids; Magnesium Chloride; Potassium Acetate; Potassium Chloride; Sodium Acetate, Amino Acids.

As of Nov 13, 2026, NDA 17957 (Veinamine 8%, Novamine 8.5%, Novamine 11.4%), held by Hospira Inc, was first approved by FDA on Jan 3, 1978, with 30 approved supplements and 0 published complete response letters.

First approved: Jan 3, 1978
Review: Standard
Supplements approved: 30
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 31 submissions below

Date	Submission	Status	Documents
Jan 3, 1978	Original applicationNew dosage form · Standard review	Approved	None posted

Products

4 strengths and forms


Veinamine 8%8%;61MG/100ML;211MG/100ML;56MG/100ML;388MG/100ML · injectable;injection	Amino Acids; Magnesium Chloride; Potassium Acetate; Potassium Chloride; Sodium Acetate	Discontinued
Novamine 8.5%8.5% (8.5GM/100ML) · injectable;injection	Amino Acids	Discontinued
Novamine 11.4%11.4% (11.4GM/100ML) · injectable;injection	Amino Acids	Discontinued
Novamine 15%15% (75GM/500ML) · injectable;injection	Amino Acids	Discontinued

All 31 submissions, including labeling and manufacturing supplements


Jan 12, 2005	Supplement 39Manufacturing · Standard review	Approved	Letter
Apr 17, 2003	Supplement 32Labeling · Standard review	Approved	Letter
Dec 21, 1999	Supplement 36Manufacturing · Standard review	Approved	None posted
Feb 9, 1995	Supplement 35Manufacturing · Standard review	Approved	None posted
Apr 28, 1993	Supplement 33Manufacturing · Standard review	Approved	None posted
Jan 11, 1993	Supplement 34Manufacturing · Standard review	Approved	None posted
Apr 5, 1990	Supplement 30Manufacturing · Standard review	Approved	None posted
Apr 5, 1990	Supplement 29Manufacturing · Standard review	Approved	None posted
Apr 10, 1989	Supplement 28Manufacturing · Standard review	Approved	None posted
Sep 17, 1987	Supplement 27Manufacturing · Standard review	Approved	None posted
Apr 30, 1987	Supplement 26Labeling · Standard review	Approved	None posted
Mar 26, 1987	Supplement 25Manufacturing · Standard review	Approved	None posted
Nov 28, 1986	Supplement 23Manufacturing · Standard review	Approved	None posted
Nov 28, 1986	Supplement 22Labeling · Standard review	Approved	None posted
Apr 4, 1986	Supplement 24Manufacturing · Standard review	Approved	None posted
Nov 1, 1985	Supplement 17Manufacturing · Standard review	Approved	None posted
Apr 23, 1985	Supplement 21Labeling · Standard review	Approved	None posted
Apr 23, 1985	Supplement 20Manufacturing · Standard review	Approved	None posted
Jul 27, 1984	Supplement 19Manufacturing · Standard review	Approved	None posted
Jan 19, 1984	Supplement 16Manufacturing · Standard review	Approved	None posted
Jun 22, 1983	Supplement 14Labeling · Standard review	Approved	None posted
Jun 7, 1983	Supplement 13Labeling · Standard review	Approved	None posted
Aug 9, 1982	Supplement 12Manufacturing · Standard review	Approved	None posted
Aug 9, 1982	Supplement 10Labeling · Standard review	Approved	None posted
May 5, 1982	Supplement 11Manufacturing · Standard review	Approved	None posted
Jul 8, 1981	Supplement 9Manufacturing · Standard review	Approved	None posted
Jun 17, 1981	Supplement 8Manufacturing · Standard review	Approved	None posted
May 9, 1979	Supplement 5Manufacturing · Standard review	Approved	None posted
Apr 9, 1979	Supplement 4Manufacturing · Standard review	Approved	None posted
Mar 26, 1979	Supplement 3Manufacturing · Standard review	Approved	None posted
Jan 3, 1978	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 17957
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