Lowers the risk of major cardiovascular events. ANDA 208544, held by Aurobindo Pharma Ltd. Rivaroxaban.
As of Nov 13, 2026, ANDA 208544 (Rivaroxaban), held by Aurobindo Pharma Ltd, was first approved by FDA on May 15, 2025, with 0 approved supplements and 0 published complete response letters.
Rivaroxaban tablets are a factor Xa inhibitor indicated: to reduce the risk of major cardiovascular events in patients with coronary artery disease (CAD) to reduce the risk of major thrombotic vascular events in patients with peripheral artery disease (PAD), including patients after recent lower extremity revascularization due to symptomatic PAD 1.7 Reduction of Risk of Major Cardiovascular Events in Patients with Coronary Artery Disease (CAD) Rivaroxaban tablets, in combination with aspirin, is indicated to reduce the risk of major cardiovascular events (cardiovascular death, myocardial infarction, and stroke) in adult patients with coronary artery disease. 1.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 15, 2025 | Original application | Approved | None posted |
| Apr 10, 2025 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Rivaroxaban2.5MG · tablet;oral | Rivaroxaban | Rx |
| Rivaroxaban10MG · tablet;oral | Rivaroxaban | Rx |
| Rivaroxaban15MG · tablet;oral | Rivaroxaban | Rx |
| Rivaroxaban20MG · tablet;oral | Rivaroxaban | Rx |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
