Heparin Sodium 20,000 Units And Dextrose 5% In Plastic Container, Heparin Sodium 10,000 Units And Dextrose 5% In Plastic Container, Heparin Sodium 25,000 Units And Dextrose 5% In Plastic Container

NDA 18814, held by Baxter Hlthcare. Heparin Sodium.

As of Nov 14, 2026, NDA 18814 (Heparin Sodium 20,000 Units And Dextrose 5% In Plastic Container, Heparin Sodium 10,000 Units And Dextrose 5% In Plastic Container, Heparin Sodium 25,000 Units And Dextrose 5% In Plastic Container), held by Baxter Hlthcare, was first approved by FDA on Oct 31, 1983, with 24 approved supplements and 0 published complete response letters.

First approved: Oct 31, 1983
Review: Standard
Supplements approved: 24
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 25 submissions below


Jul 9, 1985	Supplement 6Efficacy (new indication or use) · Standard review	Approved	None posted
Oct 31, 1983	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

4 strengths and forms


Heparin Sodium 20,000 Units And Dextrose 5% In Plastic Container4,000 UNITS/100ML · injectable;injection	Heparin Sodium	Discontinued
Heparin Sodium 10,000 Units And Dextrose 5% In Plastic Container2,000 UNITS/100ML · injectable;injection	Heparin Sodium	Discontinued
Heparin Sodium 25,000 Units And Dextrose 5% In Plastic Container5,000 UNITS/100ML · injectable;injection	Heparin Sodium	Discontinued
Heparin Sodium 25,000 Units And Dextrose 5% In Plastic Container10,000 UNITS/100ML · injectable;injection	Heparin Sodium	Discontinued

All 25 submissions, including labeling and manufacturing supplements


Aug 13, 2010	Supplement 32Labeling · Standard review	Approved	Label Letter
Oct 19, 2000	Supplement 26Labeling · Standard review	Approved	None posted
Feb 4, 2000	Supplement 24Labeling · Standard review	Approved	None posted
Nov 23, 1999	Supplement 27Manufacturing · Standard review	Approved	None posted
Jun 1, 1999	Supplement 25Manufacturing · Standard review	Approved	None posted
Sep 17, 1996	Supplement 22Labeling · Standard review	Approved	None posted
Sep 14, 1994	Supplement 20Manufacturing · Standard review	Approved	None posted
Jul 20, 1994	Supplement 19Manufacturing · Standard review	Approved	None posted
Jul 20, 1994	Supplement 18Manufacturing · Standard review	Approved	None posted
Mar 10, 1994	Supplement 21Manufacturing · Standard review	Approved	None posted
Apr 15, 1993	Supplement 17Manufacturing · Standard review	Approved	None posted
Nov 19, 1992	Supplement 13Labeling · Standard review	Approved	None posted
Jul 16, 1991	Supplement 15Manufacturing · Standard review	Approved	None posted
Apr 25, 1991	Supplement 11Manufacturing · Standard review	Approved	None posted
Mar 4, 1991	Supplement 12Manufacturing · Standard review	Approved	None posted
Aug 24, 1989	Supplement 10Manufacturing · Standard review	Approved	None posted
Feb 19, 1988	Supplement 9Labeling · Standard review	Approved	None posted
Jul 8, 1987	Supplement 8Manufacturing · Standard review	Approved	None posted
Oct 8, 1985	Supplement 7Manufacturing · Standard review	Approved	None posted
Jul 9, 1985	Supplement 6Efficacy (new indication or use) · Standard review	Approved	None posted
Jun 17, 1985	Supplement 5Manufacturing · Standard review	Approved	None posted
Jan 31, 1985	Supplement 4Labeling · Standard review	Approved	None posted
Oct 16, 1984	Supplement 2Manufacturing · Standard review	Approved	None posted
Jun 8, 1984	Supplement 1Manufacturing · Standard review	Approved	None posted
Oct 31, 1983	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 18814
Drugs@FDA: Overview at FDA
Company: Baxter Healthcare

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