Heparin Sodium 20,000 Units In Dextrose 5% In Plastic Container, Heparin Sodium 25,000 Units In Dextrose 5% In Plastic Container

NDA 19805, held by Hospira. Heparin Sodium.

As of Nov 13, 2026, NDA 19805 (Heparin Sodium 20,000 Units In Dextrose 5% In Plastic Container, Heparin Sodium 25,000 Units In Dextrose 5% In Plastic Container), held by Hospira, was first approved by FDA on Jan 25, 1989, with 17 approved supplements and 0 published complete response letters.

First approved: Jan 25, 1989
Review: Standard
Supplements approved: 17
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 18 submissions below

Date	Submission	Status	Documents
Jan 25, 1989	Original applicationNew formulation or manufacturer · Standard review	Approved	Review

Products

2 strengths and forms

Product	Active ingredient	Marketing
Heparin Sodium 20,000 Units In Dextrose 5% In Plastic Container4,000 UNITS/100ML · injectable;injection	Heparin Sodium	Discontinued
Heparin Sodium 25,000 Units In Dextrose 5% In Plastic Container5,000 UNITS/100ML · injectable;injection	Heparin Sodium	Discontinued

All 18 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Sep 4, 2019	Supplement 34Labeling · Standard review	Approved	Letter Label
Aug 1, 2019	Supplement 42Labeling · Standard review	Approved	Label Letter
Mar 13, 2014	Supplement 36Labeling · Standard review	Approved	Label Letter
Feb 8, 2013	Supplement 32Manufacturing · Standard review	Approved	None posted
Dec 23, 2011	Supplement 29Labeling · Standard review	Approved	Letter Label
Sep 18, 2002	Supplement 15Manufacturing · Standard review	Approved	None posted
Mar 16, 2000	Supplement 14Labeling · Standard review	Approved	None posted
May 27, 1998	Supplement 12Labeling · Standard review	Approved	None posted
Nov 25, 1997	Supplement 13Manufacturing · Standard review	Approved	None posted
Sep 5, 1996	Supplement 9Manufacturing · Standard review	Approved	None posted
Aug 30, 1996	Supplement 8Manufacturing · Standard review	Approved	None posted
Aug 29, 1996	Supplement 11Manufacturing · Standard review	Approved	None posted
Aug 24, 1995	Supplement 10Manufacturing · Standard review	Approved	None posted
Feb 25, 1992	Supplement 7Manufacturing · Standard review	Approved	None posted
Feb 18, 1992	Supplement 5Manufacturing · Standard review	Approved	None posted
Oct 16, 1990	Supplement 4Manufacturing · Standard review	Approved	None posted
Feb 16, 1990	Supplement 3Manufacturing · Standard review	Approved	None posted
Jan 25, 1989	Original applicationNew formulation or manufacturer · Standard review	Approved	Review

Identifiers

Application: NDA 19805
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