Enoxaparin Sodium (Preservative Free)

Prevents severely restricted mobility during acute illness. ANDA 218775, held by Hebei Changshan. Enoxaparin Sodium.

As of Nov 15, 2026, ANDA 218775 (Enoxaparin Sodium (Preservative Free)), held by Hebei Changshan, was first approved by FDA on Jan 7, 2026, with 0 approved supplements and 0 published complete response letters.

First approved: Jan 7, 2026
Review: Standard
Supplements approved: 0
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

Date	Submission	Status	Documents
Jan 7, 2026	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

Identifiers

Application: ANDA 218775
Drugs@FDA: Overview at FDA
Company: Hebei Changshan Biochemical Pharmaceutical

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