Lowers the risk of major cardiovascular events. ANDA 208546, held by Msn. Rivaroxaban.
As of Nov 13, 2026, ANDA 208546 (Rivaroxaban), held by Msn, was first approved by FDA on Oct 24, 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 |
|---|---|---|---|
| Oct 24, 2025 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Rivaroxaban2.5MG · tablet;oral | Rivaroxaban | Rx |
| Rivaroxaban10MG · tablet;oral | Rivaroxaban | Discontinued |
| Rivaroxaban15MG · tablet;oral | Rivaroxaban | Discontinued |
| Rivaroxaban20MG · tablet;oral | Rivaroxaban | Discontinued |
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
