Lowers the risk of stroke and systemic embolism. NDA 202155, held by Bristol Myers Squibb. Apixaban.
As of Nov 13, 2026, NDA 202155 (Eliquis), held by Bristol Myers Squibb, was first approved by FDA on Dec 28, 2012, with 24 approved supplements and 0 published complete response letters.
ELIQUIS is a factor Xa inhibitor indicated: to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in patients who have undergone hip or knee replacement surgery. for the treatment of DVT and PE, and for the reduction in the risk of recurrent DVT and PE following initial therapy. (1.3, 1.4, 1.5) 1.1 Reduction of Risk of Stroke and Systemic Embolism in Nonvalvular Atrial Fibrillation ELIQUIS is indicated to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. 1.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 17, 2025 | Supplement 40Efficacy (new indication or use) · Priority review | Approved | |
| Apr 17, 2025 | Supplement 39Efficacy (new indication or use) · Priority review | Approved | |
| Aug 21, 2014 | Supplement 6Efficacy (new indication or use) · Standard review | Approved | |
| Mar 13, 2014 | Supplement 3Efficacy (new indication or use) · Standard review | Approved | |
| Dec 28, 2012 | Original applicationNew molecular entity · Priority review | Approved |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 24, 2026 | Supplement 42Labeling · Standard review | Approved | |
| Apr 17, 2025 | Supplement 40Efficacy (new indication or use) · Priority review | Approved | |
| Apr 17, 2025 | Supplement 39Efficacy (new indication or use) · Priority review | Approved | |
| Oct 12, 2021 | Supplement 34Labeling · Standard review | Approved | |
| Apr 20, 2021 | Supplement 32Labeling · Standard review | Approved | |
| Nov 26, 2019 | Supplement 24Labeling · Standard review | Approved | |
| Jun 3, 2019 | Supplement 21Labeling · Standard review | Approved | |
| Jun 28, 2018 | Supplement 20Labeling · Standard review | Approved | |
| Feb 9, 2018 | Supplement 18Labeling · Standard review | Approved | |
| Nov 29, 2017 | Supplement 17Labeling · Standard review | Approved | |
| Jul 20, 2016 | Supplement 12Labeling · Standard review | Approved | |
| May 3, 2016 | Supplement 13Manufacturing · Priority review | Approved | |
| Mar 2, 2016 | Supplement 14REMS | Approved | |
| Sep 10, 2015 | Supplement 11Labeling · Standard review | Approved | |
| Jun 16, 2015 | Supplement 10Labeling · Standard review | Approved | |
| May 1, 2015 | Supplement 8Manufacturing · Priority review | Approved | None posted |
| Mar 9, 2015 | Supplement 5Manufacturing · Priority review | Approved | None posted |
| Aug 21, 2014 | Supplement 6Efficacy (new indication or use) · Standard review | Approved | |
| Aug 12, 2014 | Supplement 9REMS | Approved | |
| Apr 30, 2014 | Supplement 7Manufacturing · Priority review | Approved | None posted |
| Mar 13, 2014 | Supplement 3Efficacy (new indication or use) · Standard review | Approved | |
| Jan 30, 2014 | Supplement 2Labeling · Standard review | Approved | |
| Oct 31, 2013 | Supplement 4Labeling · Standard review | Approved | |
| Jul 16, 2013 | Supplement 1Manufacturing · Priority review | Approved | None posted |
| Dec 28, 2012 | Original applicationNew molecular entity · Priority review | 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
