cariprazine Oral Capsule

Brand(s)
Vraylar
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Actavis Pharma, Inc. (2015-09-21)
Oldest Current Product
2015-09-17
License(s)
NDA
RxNORM
ORAL CAPSULE\CARIPRAZINE
FDAOB
ORAL\CAPSULE\CARIPRAZINE HYDROCHLORIDE
SPL Active
ORAL\CAPSULE, GELATIN COATED\CARIPRAZINE
SPL Moiety
ORAL\CAPSULE, GELATIN COATED\CARIPRAZINE

product(s) by strength(s)

cariprazine 1.5 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1618740115VraylarNDAActavis Pharma, Inc.2015-09-17CARIPRAZINEORALCAPSULE, GELATIN COATEDNDA2043704b5f7c65-aa2d-452a-b3db-bc85c06ff12f

cariprazine 3 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1618740130VraylarNDAActavis Pharma, Inc.2015-09-17CARIPRAZINEORALCAPSULE, GELATIN COATEDNDA2043704b5f7c65-aa2d-452a-b3db-bc85c06ff12f

cariprazine 4.5 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1618740145VraylarNDAActavis Pharma, Inc.2015-09-17CARIPRAZINEORALCAPSULE, GELATIN COATEDNDA2043704b5f7c65-aa2d-452a-b3db-bc85c06ff12f

cariprazine 6 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1618740160VraylarNDAActavis Pharma, Inc.2015-09-17CARIPRAZINEORALCAPSULE, GELATIN COATEDNDA2043704b5f7c65-aa2d-452a-b3db-bc85c06ff12f

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA204370VRAYLARFOREST RESEARCH INSTITUTE INC2015-09-17p7943621, SUBSTANCE
p7737142, TREATMENT OF SCHIZOPHRENIA AND/OR ACUTE MANIC OR MIXED EPISODES ASSOCIATED WITH BIPOLAR I DISORDER WITH CARIPRAZINE, SUBSTANCE
NEW CHEMICAL ENTITY [2020-09-17]NDA204370_001, NDA204370_002, NDA204370_003, NDA204370_004

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA204370_001RXCARIPRAZINE HYDROCHLORIDE (EQ 1.5MG BASE)ORALCAPSULEFalse2015-09-17VRAYLAR
2NDA204370_002RXCARIPRAZINE HYDROCHLORIDE (EQ 3MG BASE)ORALCAPSULEFalse2015-09-17VRAYLAR
3NDA204370_003RXCARIPRAZINE HYDROCHLORIDE (EQ 4.5MG BASE)ORALCAPSULEFalse2015-09-17VRAYLAR
4NDA204370_004RXCARIPRAZINE HYDROCHLORIDE (EQ 6MG BASE)ORALCAPSULETrue2015-09-17VRAYLAR

patent(s)

#idexpiration dateapplication(s)
1p7737142 (view patent)2027-03-27NDA204370
2p7943621 (view patent)2028-12-16NDA204370

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
14b5f7c65-aa2d-452a-b3db-bc85c06ff12f (view SPL)These highlights do not include all the information needed to use VRAYLAR safely and effectively. See full prescribing information for VRAYLAR. VRAYLAR (cariprazine) capsules, for oral useInitial U.S. Approval: 2015prescriptionHuman PrescriptionActavis Pharma, Inc.ANALYSIS, MANUFACTURE2015-09-212618740115, 618740130, 618740145, 618740160

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII