Rivaroxaban
ANDA 216255, held by Epic Pharma LLC. Rivaroxaban.
- First approved: Aug 19, 2026
- Review: Standard
- Supplements approved: 0
- Complete response letters: 0
Approvals and New Uses
The original application and every efficacy supplement, newest first| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 19, 2026 | Original application | Approved | None posted |
Products
4 strengths and forms| 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 |
Identifiers
- Application
- ANDA 216255
- Drugs@FDA
- Overview at FDA
- Company
- Epic Pharma
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