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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 204370
Company: ABBVIE

Medication Guide

Products on NDA 204370

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
VRAYLAR	CARIPRAZINE HYDROCHLORIDE	EQ 1.5MG BASE	CAPSULE;ORAL	Prescription	AB	Yes	Yes
VRAYLAR	CARIPRAZINE HYDROCHLORIDE	EQ 3MG BASE	CAPSULE;ORAL	Prescription	AB	Yes	No
VRAYLAR	CARIPRAZINE HYDROCHLORIDE	EQ 4.5MG BASE	CAPSULE;ORAL	Prescription	AB	Yes	No
VRAYLAR	CARIPRAZINE HYDROCHLORIDE	EQ 6MG BASE	CAPSULE;ORAL	Prescription	AB	Yes	No
VRAYLAR	CARIPRAZINE HYDROCHLORIDE	EQ 0.5MG BASE	CAPSULE;ORAL	Prescription	None	Yes	No
VRAYLAR	CARIPRAZINE HYDROCHLORIDE	EQ 0.75MG BASE	CAPSULE;ORAL	Prescription	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 204370

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/17/2015	ORIG-2	Approval	Efficacy	STANDARD		Label is not available on this site.
09/17/2015	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204370lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204370Orig1Orig2s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/204370Orig2s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/18/2025	SUPPL-17	Efficacy-New Patient Population	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/204370s014s015s016s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/204370Orig1s014,s015,s016,s017ltr.pdf
12/18/2025	SUPPL-16	Efficacy-New Patient Population	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/204370s014s015s016s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/204370Orig1s014,s015,s016,s017ltr.pdf
12/18/2025	SUPPL-15	Efficacy-New Patient Population	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/204370s014s015s016s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/204370Orig1s014,s015,s016,s017ltr.pdf
12/18/2025	SUPPL-14	Efficacy-New Dosing Regimen	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/204370s014s015s016s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/204370Orig1s014,s015,s016,s017ltr.pdf
11/22/2024	SUPPL-12	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/204370s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/204370Orig1s012ltr.pdf
12/16/2022	SUPPL-9	Efficacy-New Indication	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/204370s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/204370Orig1s009ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2026/204370Orig1s009.pdf
05/24/2019	SUPPL-6	Efficacy-New Indication	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/204370s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/204370Orig1s006ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2026/204370Orig1s006.pdf
11/28/2018	SUPPL-5	Labeling-Package Insert	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/204370Orig1s005ltr.pdf
11/09/2017	SUPPL-3	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204370s002s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/0204370Orig1s002s003ltr.pdf
11/09/2017	SUPPL-2	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204370s002s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/0204370Orig1s002s003ltr.pdf
02/23/2017	SUPPL-1	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204370s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204370Orig1s001ltr.pdf

Labels for NDA 204370

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/18/2025	SUPPL-17	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/204370s014s015s016s017lbl.pdf
12/18/2025	SUPPL-16	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/204370s014s015s016s017lbl.pdf
12/18/2025	SUPPL-15	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/204370s014s015s016s017lbl.pdf
12/18/2025	SUPPL-14	Efficacy-New Dosing Regimen	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/204370s014s015s016s017lbl.pdf
11/22/2024	SUPPL-12	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/204370s012lbl.pdf
11/22/2024	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/204370s012lbl.pdf
12/16/2022	SUPPL-9	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/204370s009lbl.pdf
05/24/2019	SUPPL-6	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/204370s006lbl.pdf
11/09/2017	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204370s002s003lbl.pdf
11/09/2017	SUPPL-2	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204370s002s003lbl.pdf
02/23/2017	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204370s001lbl.pdf
09/17/2015	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204370lbl.pdf

Therapeutic Equivalents for NDA 204370

VRAYLAR

CAPSULE;ORAL; EQ 1.5MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
VRAYLAR	CARIPRAZINE HYDROCHLORIDE	EQ 1.5MG BASE	CAPSULE;ORAL	Prescription	Yes	AB	204370	ABBVIE

CAPSULE;ORAL; EQ 3MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
VRAYLAR	CARIPRAZINE HYDROCHLORIDE	EQ 3MG BASE	CAPSULE;ORAL	Prescription	Yes	AB	204370	ABBVIE

CAPSULE;ORAL; EQ 4.5MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
VRAYLAR	CARIPRAZINE HYDROCHLORIDE	EQ 4.5MG BASE	CAPSULE;ORAL	Prescription	Yes	AB	204370	ABBVIE

CAPSULE;ORAL; EQ 6MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
VRAYLAR	CARIPRAZINE HYDROCHLORIDE	EQ 6MG BASE	CAPSULE;ORAL	Prescription	Yes	AB	204370	ABBVIE

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