NDA 221033, held by Rosemont Pharms. Rivaroxaban.
As of Nov 13, 2026, NDA 221033 (Yulzety), held by Rosemont Pharms, was first approved by FDA on Oct 16, 2026, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 16, 2026 | Original applicationNew dosage form · Standard review | Approved |
| Yulzety2MG/ML · suspension;oral | Rivaroxaban | RxReference drug |
| Yulzety4MG/ML · suspension;oral | Rivaroxaban | RxReference drug |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
