Prevents severely restricted mobility during acute illness Inpatient treatment of acute…. ANDA 76684, held by Amphastar Pharm. Enoxaparin Sodium.
As of Nov 15, 2026, ANDA 76684 (Enoxaparin Sodium (Preservative Free)), held by Amphastar Pharm, was first approved by FDA on Sep 19, 2011, with 4 approved supplements 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 |
|---|---|---|---|
| Sep 19, 2011 | Original application | Approved |
| 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 |
| Nov 15, 2022 | Supplement 16Labeling · Standard review | Approved | None posted |
| Oct 30, 2020 | Supplement 11Labeling · Standard review | Approved | None posted |
| Oct 24, 2014 | Supplement 3Manufacturing | Approved | None posted |
| Aug 24, 2012 | Supplement 4Labeling · Standard review | Approved | None posted |
| Sep 19, 2011 | Original application | Approved |
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
