Lowers the risk of stroke and systemic embolism in nonvalvular atrial fibrillation. ANDA 216995, held by Aiping Pharm Inc. Rivaroxaban.
As of Nov 13, 2026, ANDA 216995 (Rivaroxaban), held by Aiping Pharm Inc, 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 risk of stroke and systemic embolism in nonvalvular atrial fibrillation for treatment of deep vein thrombosis (DVT) for treatment of pulmonary embolism (PE) for reduction in the risk of recurrence of DVT or PE for the prophylaxis of DVT, which may lead to PE in patients undergoing knee or hip replacement surgery for prophylaxis of venous thromboembolism (VTE) in acutely ill medical patients 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 extremit…
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 14, 2025 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| 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
