ANDA 210013, held by Micro Labs. Apixaban.
As of Nov 15, 2026, ANDA 210013 (Apixaban), held by Micro Labs, was first approved by FDA on Dec 23, 2019, with 2 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 23, 2019 | Original application | Approved |
| May 20, 2022 | Supplement 1Labeling · Standard review | Approved | None posted |
| May 20, 2022 | Supplement 2Labeling · Standard review | Approved | None posted |
| Dec 23, 2019 | 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
