ANDA 210066, held by Hetero Labs Ltd V. Apixaban.
As of Nov 15, 2026, ANDA 210066 (Apixaban), held by Hetero Labs Ltd V, was first approved by FDA on Nov 21, 2023, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 21, 2023 | Original application | Approved |
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