ANDA 212247, held by Teva Pharms USA. Rivaroxaban.
As of Nov 13, 2026, ANDA 212247 (Rivaroxaban), held by Teva Pharms USA, was first approved by FDA on Oct 27, 2026, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 27, 2026 | 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
