Treats VTE and reduction in the risk of recurrent VTE. ANDA 218502, held by Alkem Labs Ltd. Rivaroxaban.
As of Nov 13, 2026, ANDA 218502 (Rivaroxaban), held by Alkem Labs Ltd, was first approved by FDA on Jun 26, 2025, with 0 approved supplements and 0 published complete response letters.
Rivaroxaban for oral suspension is a factor Xa inhibitor indicated: for treatment of VTE and reduction in the risk of recurrent VTE in pediatric patients from birth to less than 18 years for thromboprophylaxis in pediatric patients 2 years and older with congenital heart disease after the Fontan procedure 1.9 Treatment of Venous Thromboembolism and Reduction in Risk of Recurrent Venous Thromboembolism in Pediatric Patients Rivaroxaban for oral suspension is indicated for the treatment of venous thromboembolism (VTE) and the reduction in the risk of recurrent VTE in pediatric patients from birth to less than 18 years after at least 5 days of initial parenteral anticoagulant treatment. 1.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 26, 2025 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Rivaroxaban1MG/ML · for suspension;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
