Heparin Sodium 1,000 Units And Sodium Chloride 0.9% In Plastic Container, Heparin Sodium 2,000 Units And Sodium Chloride 0.9% In Plastic Container, Heparin Sodium 5,000 Units And Sodium Chloride 0.9% In Plastic Container

NDA 18609, held by Baxter Hlthcare. Heparin Sodium.

As of Nov 14, 2026, NDA 18609 (Heparin Sodium 1,000 Units And Sodium Chloride 0.9% In Plastic Container, Heparin Sodium 2,000 Units And Sodium Chloride 0.9% In Plastic Container, Heparin Sodium 5,000 Units And Sodium Chloride 0.9% In Plastic Container), held by Baxter Hlthcare, was first approved by FDA on Apr 28, 1982, with 38 approved supplements and 0 published complete response letters.

First approved: Apr 28, 1982
Review: Standard
Supplements approved: 38
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Heparin Sodium in Sodium Chloride Injection at a concentration of 2 units/mL is indicated as an anticoagulant to maintain catheter patency.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 39 submissions below

Date	Submission	Status	Documents
Apr 28, 1982	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

4 strengths and forms


Heparin Sodium 1,000 Units And Sodium Chloride 0.9% In Plastic Container200 UNITS/100ML · injectable;injection	Heparin Sodium	Rx
Heparin Sodium 2,000 Units And Sodium Chloride 0.9% In Plastic Container200 UNITS/100ML · injectable;injection	Heparin Sodium	Rx
Heparin Sodium 5,000 Units And Sodium Chloride 0.9% In Plastic Container500 UNITS/100ML · injectable;injection	Heparin Sodium	Discontinued
Heparin Sodium 2,000 Units And Sodium Chloride 0.9% In Plastic Container2,000 UNITS/1000ML · injectable;injection	Heparin Sodium	Rx

All 39 submissions, including labeling and manufacturing supplements


Jan 3, 2022	Supplement 58Labeling · Standard review	Approved	Label Letter
Jul 15, 2019	Supplement 54Labeling · Standard review	Approved	Letter Label
Jul 25, 2016	Supplement 50Manufacturing · Standard review	Approved	None posted
Aug 18, 2015	Supplement 49Manufacturing · Standard review	Approved	None posted
Feb 27, 2012	Supplement 42Labeling · Standard review	Approved	Letter
Aug 13, 2010	Supplement 44Labeling	Approved	Label Letter
Aug 21, 2001	Supplement 35Labeling · Standard review	Approved	Review Label
Aug 21, 2001	Supplement 33Labeling · Standard review	Approved	Review Label
Aug 14, 2001	Supplement 37Manufacturing · Standard review	Approved	None posted
Nov 23, 1999	Supplement 36Manufacturing · Standard review	Approved	None posted
Jun 1, 1999	Supplement 34Manufacturing · Standard review	Approved	None posted
May 20, 1997	Supplement 32Manufacturing · Standard review	Approved	None posted
Sep 17, 1996	Supplement 31Labeling · Standard review	Approved	None posted
Sep 14, 1994	Supplement 29Manufacturing · Standard review	Approved	None posted
Mar 10, 1994	Supplement 30Manufacturing · Standard review	Approved	None posted
Apr 15, 1993	Supplement 27Manufacturing · Standard review	Approved	None posted
Mar 4, 1991	Supplement 25Manufacturing · Standard review	Approved	None posted
Feb 1, 1991	Supplement 23Manufacturing · Standard review	Approved	None posted
Jul 26, 1990	Supplement 24Manufacturing · Standard review	Approved	None posted
Nov 8, 1989	Supplement 21Labeling	Approved	None posted
Nov 8, 1989	Supplement 15Labeling	Approved	None posted
Nov 8, 1989	Supplement 10Labeling	Approved	None posted
Aug 24, 1989	Supplement 22Manufacturing · Standard review	Approved	None posted
Apr 29, 1987	Supplement 20Manufacturing · Standard review	Approved	None posted
Dec 1, 1986	Supplement 19Manufacturing · Standard review	Approved	None posted
Dec 1, 1986	Supplement 18Manufacturing · Standard review	Approved	None posted
Sep 20, 1985	Supplement 17Manufacturing · Standard review	Approved	None posted
Sep 20, 1985	Supplement 16Manufacturing · Standard review	Approved	None posted
Oct 16, 1984	Supplement 14Manufacturing · Standard review	Approved	None posted
Aug 3, 1984	Supplement 13Manufacturing · Standard review	Approved	None posted
Mar 6, 1984	Supplement 11Labeling	Approved	None posted
Mar 6, 1984	Supplement 9Manufacturing · Standard review	Approved	None posted
Mar 6, 1984	Supplement 8Manufacturing · Standard review	Approved	None posted
Mar 6, 1984	Supplement 4Manufacturing · Standard review	Approved	None posted
Feb 28, 1984	Supplement 12Manufacturing · Standard review	Approved	None posted
Aug 9, 1982	Supplement 3Manufacturing · Standard review	Approved	None posted
Aug 9, 1982	Supplement 2Manufacturing · Standard review	Approved	None posted
Jun 29, 1982	Supplement 1Manufacturing · Standard review	Approved	None posted
Apr 28, 1982	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 18609
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