Lowers the risk of major cardiovascular events. ANDA 218117, held by Sciegen Pharms. Rivaroxaban.
As of Nov 14, 2026, ANDA 218117 (Rivaroxaban), held by Sciegen Pharms, was first approved by FDA on Jul 31, 2025, with 0 approved supplements and 0 published complete response letters.
Rivaroxaban Tablets is 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 |
|---|---|---|---|
| Jul 31, 2025 | Original application | Approved | None posted |
| 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 daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
