Prevents severely restricted mobility during acute illness Inpatient treatment of acute…. ANDA 208600, held by Amphastar Pharms Inc. Enoxaparin Sodium.
As of Nov 15, 2026, ANDA 208600 (Enoxaparin Sodium), held by Amphastar Pharms Inc, was first approved by FDA on Mar 14, 2019, with 1 approved supplement and 0 published complete response letters.
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.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 14, 2019 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Enoxaparin Sodium300MG/3ML (100MG/ML) · injectable;intravenous, subcutaneous | Enoxaparin Sodium | Rx |
| Nov 15, 2022 | Supplement 2Labeling · Standard review | Approved | None posted |
| Mar 14, 2019 | Original application | Approved | None posted |
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
