ANDA 209944, held by Sunshine Lake. Apixaban.
As of Nov 15, 2026, ANDA 209944 (Apixaban), held by Sunshine Lake, was not approved, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 10, 2019 | Original application | 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