Lowers the risk of major cardiovascular events. ANDA 208555, held by Lupin. Rivaroxaban.
As of Nov 13, 2026, ANDA 208555 (Rivaroxaban), held by Lupin, was first approved by FDA on May 14, 2025, with 0 approved supplements and 0 published complete response letters.
Rivaroxaban 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, are 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 14, 2025 | Original application | Approved | None posted |
| Mar 3, 2025 | Original application | Approved | None posted |
| 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
