Heparin Sodium, Heparin Sodium Preservative Free

Treats venous thrombosis and pulmonary embolism. NDA 201370, held by Pfizer. Heparin Sodium.

As of Nov 13, 2026, NDA 201370 (Heparin Sodium, Heparin Sodium Preservative Free), held by Pfizer, was first approved by FDA on Jul 21, 2011, with 10 approved supplements and 0 published complete response letters.

First approved: Jul 21, 2011
Review: Standard
Supplements approved: 10
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

HEPARIN SODIUM INJECTION is indicated for:

Prophylaxis and treatment of venous thrombosis and pulmonary embolism;
Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation;
Treatment of acute and chronic consumption coagulopathies (disseminated intravascular coagulation);
Prevention of clotting in arterial and cardiac surgery;
Prophylaxis and treatment of peripheral arterial embolism;
Anticoagulant use in blood transfusions, extracorporeal circulation, and dialysis procedures.

Full prescribing information on DailyMed ↗

Approvals and New Uses

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

Date	Submission	Status	Documents
Jul 21, 2011	Original applicationNew formulation or manufacturer · Standard review	Approved	Review Summary Review Letter Label

Products

4 strengths and forms

Product	Active ingredient	Marketing
Heparin Sodium1,000 UNITS/ML · injectable;injection	Heparin Sodium	DiscontinuedReference drug
Heparin Sodium5,000 UNITS/ML · injectable;injection	Heparin Sodium	DiscontinuedReference drug
Heparin Sodium10,000 UNITS/ML · injectable;injection	Heparin Sodium	DiscontinuedReference drug
Heparin Sodium Preservative Free1,000 UNITS/ML · injectable;injection	Heparin Sodium	RxReference drug

All 11 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Sep 24, 2025	Supplement 22Labeling · Standard review	Approved	Letter Label
Oct 24, 2024	Supplement 21Labeling · Standard review	Approved	Letter Label
Sep 19, 2019	Supplement 14Labeling · Standard review	Approved	Letter Label
Sep 19, 2019	Supplement 13Labeling · Standard review	Approved	Letter Label
Aug 9, 2016	Supplement 10Labeling · Standard review	Approved	Label Letter
Mar 3, 2015	Supplement 8Manufacturing · Standard review	Approved	None posted
Dec 5, 2014	Supplement 9Manufacturing · Standard review	Approved	None posted
Apr 22, 2014	Supplement 5Labeling · Standard review	Approved	None posted
Apr 22, 2014	Supplement 4Labeling · Standard review	Approved	None posted
Dec 11, 2012	Supplement 3Labeling · Standard review	Approved	None posted
Jul 21, 2011	Original applicationNew formulation or manufacturer · Standard review	Approved	Review Summary Review Letter Label

Identifiers

Application: NDA 201370
Drugs@FDA: Overview at FDA
Company: Pfizer

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