ANDA 213903, held by Zhejiang Yongning Pharmaceutical Co Ltd. Apixaban.
As of Nov 15, 2026, ANDA 213903 (Apixaban), held by Zhejiang Yongning Pharmaceutical Co Ltd, was not approved, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 21, 2022 | Original application | Tentative approval | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Apixaban2.5MG ยท tablet;oral | Apixaban | None (tentative approval) |
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
