Prevents severely restricted mobility during acute illness Inpatient treatment of acute…. ANDA 78990, held by Gland. Enoxaparin Sodium.
As of Nov 15, 2026, ANDA 78990 (Enoxaparin Sodium (Preservative Free)), held by Gland, was first approved by FDA on Sep 28, 2018, 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 28, 2018 | Original application | Approved | None posted |
| 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 |
| Jun 26, 2024 | Supplement 16Labeling · Standard review | Approved | None posted |
| Jun 26, 2024 | Supplement 19Labeling · Standard review | Approved | None posted |
| Jul 28, 2022 | Supplement 12Labeling · Standard review | Approved | None posted |
| Mar 19, 2020 | Supplement 3Labeling · Standard review | Approved | None posted |
| Sep 28, 2018 | 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
