Treats schizophrenia. NDA 204370, held by Abbvie. Cariprazine Hydrochloride.
As of Nov 14, 2026, NDA 204370 (Vraylar), held by Abbvie, was first approved by FDA on Sep 17, 2015, with 11 approved supplements and 0 published complete response letters.
| Dec 18, 2025 | Supplement 14Efficacy (new indication or use) · Standard review | Approved | |
| Dec 18, 2025 | Supplement 15Efficacy (new indication or use) · Priority review | Approved | |
| Dec 18, 2025 | Supplement 16Efficacy (new indication or use) · Priority review | Approved | |
| Dec 18, 2025 | Supplement 17Efficacy (new indication or use) · Priority review | Approved | |
| Dec 16, 2022 | Supplement 9Efficacy (new indication or use) · Standard review | Approved | |
| May 24, 2019 | Supplement 6Efficacy (new indication or use) · Standard review | Approved | |
| Nov 9, 2017 | Supplement 2Efficacy (new indication or use) · Standard review | Approved | |
| Sep 17, 2015 | Original applicationNew molecular entity · Standard review | Approved | |
| Sep 17, 2015 | Original applicationEfficacy (new indication or use) · Standard review | Approved | None posted |
| VraylarEQ 1.5MG BASE · capsule;oral | Cariprazine Hydrochloride | RxReference drug |
| VraylarEQ 3MG BASE · capsule;oral | Cariprazine Hydrochloride | RxReference drug |
| VraylarEQ 4.5MG BASE · capsule;oral | Cariprazine Hydrochloride | RxReference drug |
| VraylarEQ 6MG BASE · capsule;oral | Cariprazine Hydrochloride | RxReference drug |
| VraylarEQ 0.5MG BASE · capsule;oral | Cariprazine Hydrochloride | RxReference drug |
| VraylarEQ 0.75MG BASE · capsule;oral | Cariprazine Hydrochloride | RxReference drug |
| Dec 18, 2025 | Supplement 14Efficacy (new indication or use) · Standard review | Approved | |
| Dec 18, 2025 | Supplement 15Efficacy (new indication or use) · Priority review | Approved | |
| Dec 18, 2025 | Supplement 16Efficacy (new indication or use) · Priority review | Approved | |
| Dec 18, 2025 | Supplement 17Efficacy (new indication or use) · Priority review | Approved | |
| Nov 22, 2024 | Supplement 12Labeling · Standard review | Approved | |
| Dec 16, 2022 | Supplement 9Efficacy (new indication or use) · Standard review | Approved | |
| May 24, 2019 | Supplement 6Efficacy (new indication or use) · Standard review | Approved | |
| Nov 28, 2018 | Supplement 5Labeling · Standard review | Approved | |
| Nov 9, 2017 | Supplement 2Efficacy (new indication or use) · Standard review | Approved | |
| Nov 9, 2017 | Supplement 3Labeling · Standard review | Approved | |
| Feb 23, 2017 | Supplement 1Labeling | Approved | |
| Sep 17, 2015 | Original applicationNew molecular entity · Standard review | Approved | |
| Sep 17, 2015 | Original applicationEfficacy (new indication or use) · Standard review | Approved | None posted |
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
