Enoxaparin Sodium (Preservative Free)

Prevents severely restricted mobility during acute illness Inpatient treatment of acute…. ANDA 206834, held by Emerge Bioscience. Enoxaparin Sodium.

As of Nov 15, 2026, ANDA 206834 (Enoxaparin Sodium (Preservative Free)), held by Emerge Bioscience, was first approved by FDA on Nov 29, 2019, with 1 approved supplement and 0 published complete response letters.

First approved: Nov 29, 2019
Review: Standard
Supplements approved: 1
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Enoxaparin Sodium Injection 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 2 submissions below

Date	Submission	Status	Documents
Nov 29, 2019	Original application	Approved	None posted

Products

7 strengths and forms


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)100MG/ML (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 2 submissions, including labeling and manufacturing supplements


Jul 15, 2022	Supplement 9Labeling · Standard review	Approved	None posted
Nov 29, 2019	Original application	Approved	None posted

Identifiers

Application: ANDA 206834
Drugs@FDA: Overview at FDA
Company: Emerge Bioscience

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