Enoxaparin Sodium (Preservative Free)

Prevents severely restricted mobility during acute illness. ANDA 77857, held by Sandoz. Enoxaparin Sodium.

As of Nov 15, 2026, ANDA 77857 (Enoxaparin Sodium (Preservative Free)), held by Sandoz, was first approved by FDA on Jul 23, 2010, with 8 approved supplements and 0 published complete response letters.

First approved: Jul 23, 2010
Supplements approved: 8
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Enoxaparin sodium injection, USP is a low molecular weight heparin (LMWH) indicated for:

Prophylaxis of deep vein thrombosis (DVT) in abdominal surgery, hip replacement surgery, knee replacement surgery, or medical patients with severely restricted mobility during acute illness
Inpatient treatment of acute DVT with or without pulmonary embolism
Outpatient treatment of acute DVT without pulmonary embolism
Prophylaxis of ischemic complications of unstable angina and non-Q-wave myocardial infarction (MI)
Treatment of acute ST-segment elevation myocardial infarction (STEMI) managed medically or with subsequent percutaneous coronary intervention (PCI) 1.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 9 submissions below

Date	Submission	Status	Documents
Jul 23, 2010	Original application	Approved	Review Letter

Products

7 strengths and forms


Enoxaparin Sodium (Preservative Free)100MG/ML (100MG/ML) · injectable;subcutaneous	Enoxaparin Sodium	Rx
Enoxaparin Sodium (Preservative Free)30MG/0.3ML (100MG/ML) · injectable;subcutaneous	Enoxaparin Sodium	Rx
Enoxaparin Sodium (Preservative Free)40MG/0.4ML (100MG/ML) · injectable;subcutaneous	Enoxaparin Sodium	Rx
Enoxaparin Sodium (Preservative Free)60MG/0.6ML (100MG/ML) · injectable;subcutaneous	Enoxaparin Sodium	Rx
Enoxaparin Sodium (Preservative Free)80MG/0.8ML (100MG/ML) · injectable;subcutaneous	Enoxaparin Sodium	Rx
Enoxaparin Sodium (Preservative Free)120MG/0.8ML (150MG/ML) · injectable;subcutaneous	Enoxaparin Sodium	Rx
Enoxaparin Sodium (Preservative Free)150MG/ML (150MG/ML) · injectable;subcutaneous	Enoxaparin Sodium	Rx

All 9 submissions, including labeling and manufacturing supplements


Jun 14, 2024	Supplement 45Labeling · Standard review	Approved	None posted
Dec 9, 2022	Supplement 41Labeling · Standard review	Approved	None posted
Jun 18, 2020	Supplement 35Labeling · Standard review	Approved	None posted
Dec 28, 2015	Supplement 20Labeling · Standard review	Approved	None posted
Oct 29, 2013	Supplement 18Labeling · Standard review	Approved	None posted
Nov 22, 2011	Supplement 4Labeling	Approved	None posted
Oct 31, 2011	Supplement 8Labeling	Approved	None posted
Jul 25, 2011	Supplement 5Labeling	Approved	None posted
Jul 23, 2010	Original application	Approved	Review Letter

Identifiers

Application: ANDA 77857
Drugs@FDA: Overview at FDA
Company: Sandoz

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