Treats schizophrenia. NDA 207533, held by Alkermes Inc. Aripiprazole Lauroxil.
As of Nov 13, 2026, NDA 207533 (Aristada), held by Alkermes Inc, was first approved by FDA on Oct 5, 2015, with 9 approved supplements and 0 published complete response letters.
ARISTADA is indicated for the treatment of schizophrenia in adults.
| Jun 5, 2017 | Supplement 4Efficacy (new indication or use) · Standard review | Approved | |
| Oct 5, 2015 | Original applicationNew molecular entity · Standard review | Approved |
| Aristada441MG/1.6ML (275.63MG/ML) · suspension, extended release;intramuscular | Aripiprazole Lauroxil | RxReference drug |
| Aristada662MG/2.4ML (275.83MG/ML) · suspension, extended release;intramuscular | Aripiprazole Lauroxil | RxReference drug |
| Aristada882MG/3.2ML (275.63MG/ML) · suspension, extended release;intramuscular | Aripiprazole Lauroxil | RxReference drug |
| Aristada1064MG/3.9ML (272.82MG/ML) · suspension, extended release;intramuscular | Aripiprazole Lauroxil | RxReference drug |
| Jan 22, 2025 | Supplement 31Labeling · Standard review | Approved | |
| Mar 30, 2021 | Supplement 21Labeling · Standard review | Approved | |
| Aug 27, 2020 | Supplement 17Labeling · Standard review | Approved | |
| Nov 30, 2018 | Supplement 13Labeling · Standard review | Approved | |
| Jan 25, 2018 | Supplement 9Labeling · Standard review | Approved | |
| Jun 5, 2017 | Supplement 4Efficacy (new indication or use) · Standard review | Approved | |
| Feb 23, 2017 | Supplement 6Labeling | Approved | |
| Aug 18, 2016 | Supplement 3Labeling | Approved | |
| Mar 24, 2016 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Oct 5, 2015 | Original applicationNew molecular entity · Standard 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
