FDA.reportPublic FDA data

Application 021436

Type
NDA
Sponsor
OTSUKA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ABILIFYARIPIPRAZOLETABLET;ORAL10MGYesYes
002ABILIFYARIPIPRAZOLETABLET;ORAL15MGYesNo
003ABILIFYARIPIPRAZOLETABLET;ORAL20MGYesNo
004ABILIFYARIPIPRAZOLETABLET;ORAL30MGYesNo
005ABILIFYARIPIPRAZOLETABLET;ORAL5MGYesYes
006ABILIFYARIPIPRAZOLETABLET;ORAL2MGYesNo

Orange Book products#

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021436-001ABILIFYARIPIPRAZOLE10MGTABLET / ORALABRLD, RS2002-11-15
N021436-002ABILIFYARIPIPRAZOLE15MGTABLET / ORALABRLD2002-11-15
N021436-003ABILIFYARIPIPRAZOLE20MGTABLET / ORALABRLD2002-11-15
N021436-004ABILIFYARIPIPRAZOLE30MGTABLET / ORALABRLD2002-11-15
N021436-005ABILIFYARIPIPRAZOLE5MGTABLET / ORALABRLD2002-11-15
N021436-006ABILIFYARIPIPRAZOLE2MGTABLET / ORALABRLD2002-11-15

Therapeutic equivalence codes#

Application-product, TE code table
Application-productTE code
N021436-001AB
N021436-002AB
N021436-003AB
N021436-004AB
N021436-005AB
N021436-006AB

Orange Book patents#

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N021436-00191259392026-07-28U-17492015-10-07
N021436-00187593502027-03-02U-15292014-07-22
N021436-00291259392026-07-28U-17492015-10-07
N021436-00287593502027-03-02U-15292014-07-22
N021436-00391259392026-07-28U-17492015-10-07
N021436-00387593502027-03-02U-15292014-07-22
N021436-00491259392026-07-28U-17492015-10-07
N021436-00487593502027-03-02U-15292014-07-22
N021436-00591259392026-07-28U-17492015-10-07
N021436-00587593502027-03-02U-15292014-07-22
N021436-00691259392026-07-28U-17492015-10-07
N021436-00687593502027-03-02U-15292014-07-22

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ABILIFYARIPIPRAZOLEOtsuka America Pharmaceutical, Inc.c040bd1d-45b7-49f2-93ea-aed7220b30ac2025-01-29Boxed warning, Warnings, Adverse reactionsExact identifier

Boxed warning cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

boxed warning

WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS and SUICIDAL THOUGHTS AND BEHAVIORS WITH ANTIDEPRESSANT DRUGS Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. ABILIFY is not approved for the treatment of patients with dementia-related psychosis [see Warnings and Precautions (5.1) ] . Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies. These studies did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in patients over age 24 years; there was a reduction in risk with antidepressant use in patients aged 65 years and older [see Warnings and Precautions (5.3) ] . In patients of all ages who are started on antidepressant therapy, monitor closely for worsening, and for emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the prescriber [see Warnings and Precautions (5.3) ] . WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS and SUICIDAL THOUGHTS AND BEHAVIORS WITH ANTIDEPRESSANT DRUGS See full prescribing information for complete boxed warning. Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. ABILIFY is not approved for the treatment of patients with dementia-related psychosis. ( 5.1 ) Increased risk of suicidal thinking and behavior in children, adolescents, and young adults taking antidepressants. Monitor for worsening and emergence of suicidal thoughts and behaviors. ( 5.3 )

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings and cautions

5 WARNINGS AND PRECAUTIONS Cerebrovascular Adverse Reactions in Elderly Patients with Dementia-Related Psychosis: Increased incidence of cerebrovascular adverse reactions (e.g., stroke, transient ischemic attack, including fatalities) ( 5.1 , 5.2 ) Neuroleptic Malignant Syndrome: Manage with immediate discontinuation and close monitoring ( 5.4 ) Tardive Dyskinesia: Discontinue if clinically appropriate ( 5.5 ) Metabolic Changes: Atypical antipsychotic drugs have been associated with metabolic changes that include hyperglycemia/diabetes mellitus, dyslipidemia, and body weight gain ( 5.6 ) Hyperglycemia/Diabetes Mellitus: Monitor glucose regularly in patients with and at risk for diabetes ( 5.6 ) Dyslipidemia: Undesirable alterations in lipid levels have been observed in patients treated with atypical antipsychotics ( 5.6 ) Weight Gain: Weight gain has been observed with atypical antipsychotic use. Monitor weight ( 5.6 ) Pathological Gambling and Other Compulsive Behaviors: Consider dose reduction or discontinuation ( 5.7 ) Orthostatic Hypotension: Monitor heart rate and blood pressure and warn patients with known cardiovascular or cerebrovascular disease, and risk of dehydration or syncope ( 5.8 ) Leukopenia, Neutropenia, and Agranulocytosis: have been reported with antipsychotics including ABILIFY. Patients with a history of a clinically significant low white blood cell count (WBC) or a drug-induced leukopenia/neutropenia should have their complete blood count (CBC) monitored frequently during the first few months of therapy and discontinuation of ABILIFY should be considered at the first sign of a clinically significant decline in WBC in the absence of other causative factors ( 5.10 ) Seizures/Convulsions: Use cautiously in patients with a history of seizures or with conditions that lower the seizure threshold ( 5.11 ) Potential for Cognitive and Motor Impairment: Use caution when operating machinery ( 5.12 ) Suicide: The possibility of a suicide attempt is inherent in schizophrenia and bipolar disorder. Closely supervise high-risk patients ( 5.14 ) 5.1 Increased Mortality in Elderly Patients with Dementia-Related Psychosis Increased Mortality Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. ABILIFY (aripiprazole) is not approved for the treatment of patients with dementia-related psycho...

warnings and cautions table

Table 3:Age RangeDrug-Placebo Difference in Number of Cases of Suicidality per 1000 Patients TreatedIncreases Compared to Placebo<1814 additional cases18 to 245 additional casesDecreases Compared to Placebo25 to 641 fewer case≥656 fewer cases

Adverse reactions cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

adverse reactions

6 ADVERSE REACTIONS The following adverse reactions are discussed in more detail in other sections of the labeling: Increased Mortality in Elderly Patients with Dementia-Related Psychosis [see Boxed Warning and Warnings and Precautions (5.1) ] Cerebrovascular Adverse Events, Including Stroke [see Warnings and Precautions (5.2) ] Suicidal Thoughts and Behaviors in Children, Adolescents, and Young Adults [see Boxed Warning and Warnings and Precautions (5.3) ] Neuroleptic Malignant Syndrome (NMS) [see Warnings and Precautions (5.4) ] Tardive Dyskinesia [see Warnings and Precautions (5.5) ] Metabolic Changes [see Warnings and Precautions (5.6) ] Pathological Gambling and Other Compulsive Behaviors [see Warnings and Precautions (5.7) ] Orthostatic Hypotension [see Warnings and Precautions (5.8) ] Falls [see Warnings and Precautions (5.9) ] Leukopenia, Neutropenia, and Agranulocytosis [see Warnings and Precautions (5.10) ] Seizures/Convulsions [see Warnings and Precautions (5.11) ] Potential for Cognitive and Motor Impairment [see Warnings and Precautions (5.12) ] Body Temperature Regulation [see Warnings and Precautions (5.13) ] Suicide [see Warnings and Precautions (5.14) ] Dysphagia [see Warnings and Precautions (5.15) ] Commonly observed adverse reactions (incidence ≥5% and at least twice that for placebo) were ( 6.1 ): Adult patients with schizophrenia: akathisia Pediatric patients (13 to 17 years) with schizophrenia: extrapyramidal disorder, somnolence, and tremor Adult patients (monotherapy) with bipolar mania: akathisia, sedation, restlessness, tremor, and extrapyramidal disorder Adult patients (adjunctive therapy with lithium or valproate) with bipolar mania: akathisia, insomnia, and extrapyramidal disorder Pediatric patients (10 to 17 years) with bipolar mania: somnolence, extrapyramidal disorder, fatigue, nausea, akathisia, blurred vision, salivary hypersecretion, and dizziness Adult patients with major depressive disorder (adjunctive treatment to antidepressant therapy): akathisia, restlessness, insomnia, constipation, fatigue, and blurred vision Pediatric patients (6 to 17 years) with autistic disorder: sedation, fatigue, vomiting, somnolence, tremor, pyrexia, drooling, decreased appetite, salivary hypersecretion, extrapyramidal disorder, and lethargy Pediatric patients (6 to 18 years) with Tourette's Disorder: sedation, somnolence, nausea, headach...

adverse reactions table

Table 14: Commonly Observed Adverse Reactions in Short-Term, Placebo-Controlled Trials of Adult Patients with Bipolar Mania Treated with ABILIFY MonotherapyPreferred TermPercentage of Patients Reporting ReactionABILIFY (n=917)Placebo (n=753) Akathisia134Sedation83Restlessness63Tremor63Extrapyramidal Disorder52

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
21695-002ABILIFYARIPIPRAZOLERebel Distributors Corp.NDACurrent
21695-003ABILIFYARIPIPRAZOLERebel Distributors Corp.NDACurrent
21695-004ABILIFYARIPIPRAZOLERebel Distributors Corp.NDACurrent
21695-005ABILIFYARIPIPRAZOLERebel Distributors Corp.NDACurrent
43353-848ABILIFYARIPIPRAZOLEAphena Pharma Solutions - Tennessee, LLCNDACurrent
43353-849ABILIFYARIPIPRAZOLEAphena Pharma Solutions - Tennessee, LLCNDACurrent
43353-850ABILIFYARIPIPRAZOLEAphena Pharma Solutions - Tennessee, LLCNDACurrent
52959-604ABILIFYARIPIPRAZOLEH.J. Harkins Company, Inc.NDACurrent
55289-251ABILIFYARIPIPRAZOLEPD-Rx Pharmaceuticals, Inc.NDACurrent
55289-251ABILIFYARIPIPRAZOLEPD-Rx Pharmaceuticals, Inc.NDACurrent
55289-251ABILIFYARIPIPRAZOLEPD-Rx Pharmaceuticals, Inc.NDACurrent
55289-251ABILIFYARIPIPRAZOLEPD-Rx Pharmaceuticals, Inc.NDACurrent
55289-251ABILIFYARIPIPRAZOLEPD-Rx Pharmaceuticals, Inc.NDACurrent
55289-251ABILIFYARIPIPRAZOLEPD-Rx Pharmaceuticals, InNDACurrent
59148-006ABILIFYARIPIPRAZOLEOtsuka America Pharmaceutical, Inc.NDACurrent
59148-006ABILIFYARIPIPRAZOLEOtsuka America Pharmaceutical, Inc.NDACurrent
59148-006ABILIFYARIPIPRAZOLEOtsuka America Pharmaceutical, Inc.NDACurrent
59148-006ABILIFYARIPIPRAZOLEOtsuka America Pharmaceutical, Inc.NDACurrent
59148-006ABILIFYARIPIPRAZOLEOtsuka America Pharmaceutical, Inc.NDACurrent
59148-006ABILIFYARIPIPRAZOLEOtsuka America Pharmaceutical, Inc.NDACurrent
59148-006ABILIFYARIPIPRAZOLEOtsuka America Pharmaceutical, Inc.NDACurrent
59148-006ABILIFYARIPIPRAZOLEOtsuka America Pharmaceutical, Inc.NDACurrent
59148-007ABILIFYARIPIPRAZOLEOtsuka America Pharmaceutical, Inc.NDACurrent
59148-007ABILIFYARIPIPRAZOLEOtsuka America Pharmaceutical, Inc.NDACurrent
59148-007ABILIFYARIPIPRAZOLEOtsuka America Pharmaceutical, Inc.NDACurrent
59148-007ABILIFYARIPIPRAZOLEOtsuka America Pharmaceutical, Inc.NDACurrent
59148-007ABILIFYARIPIPRAZOLEOtsuka America Pharmaceutical, Inc.NDACurrent
59148-007ABILIFYARIPIPRAZOLEOtsuka America Pharmaceutical, Inc.NDACurrent
59148-007ABILIFYARIPIPRAZOLEOtsuka America Pharmaceutical, Inc.NDACurrent
59148-007ABILIFYARIPIPRAZOLEOtsuka America Pharmaceutical, Inc.NDACurrent
59148-008ABILIFYARIPIPRAZOLEOtsuka America Pharmaceutical, Inc.NDACurrent
59148-008ABILIFYARIPIPRAZOLEOtsuka America Pharmaceutical, Inc.NDACurrent
59148-008ABILIFYARIPIPRAZOLEOtsuka America Pharmaceutical, Inc.NDACurrent
59148-008ABILIFYARIPIPRAZOLEOtsuka America Pharmaceutical, Inc.NDACurrent
59148-008ABILIFYARIPIPRAZOLEOtsuka America Pharmaceutical, Inc.NDACurrent
59148-008ABILIFYARIPIPRAZOLEOtsuka America Pharmaceutical, Inc.NDACurrent
59148-008ABILIFYARIPIPRAZOLEOtsuka America Pharmaceutical, Inc.NDACurrent
59148-008ABILIFYARIPIPRAZOLEOtsuka America Pharmaceutical, Inc.NDACurrent
59148-009ABILIFYARIPIPRAZOLEOtsuka America Pharmaceutical, Inc.NDACurrent
59148-009ABILIFYARIPIPRAZOLEOtsuka America Pharmaceutical, Inc.NDACurrent
59148-009ABILIFYARIPIPRAZOLEOtsuka America Pharmaceutical, Inc.NDACurrent
59148-009ABILIFYARIPIPRAZOLEOtsuka America Pharmaceutical, Inc.NDACurrent
59148-009ABILIFYARIPIPRAZOLEOtsuka America Pharmaceutical, Inc.NDACurrent
59148-009ABILIFYARIPIPRAZOLEOtsuka America Pharmaceutical, Inc.NDACurrent
59148-009ABILIFYARIPIPRAZOLEOtsuka America Pharmaceutical, Inc.NDACurrent
59148-009ABILIFYARIPIPRAZOLEOtsuka America Pharmaceutical, Inc.NDACurrent
59148-010ABILIFYARIPIPRAZOLEOtsuka America Pharmaceutical, Inc.NDACurrent
59148-010ABILIFYARIPIPRAZOLEOtsuka America Pharmaceutical, Inc.NDACurrent
59148-010ABILIFYARIPIPRAZOLEOtsuka America Pharmaceutical, Inc.NDACurrent
59148-010ABILIFYARIPIPRAZOLEOtsuka America Pharmaceutical, Inc.NDACurrent
59148-010ABILIFYARIPIPRAZOLEOtsuka America Pharmaceutical, Inc.NDACurrent
59148-010ABILIFYARIPIPRAZOLEOtsuka America Pharmaceutical, Inc.NDACurrent
59148-010ABILIFYARIPIPRAZOLEOtsuka America Pharmaceutical, Inc.NDACurrent
59148-010ABILIFYARIPIPRAZOLEOtsuka America Pharmaceutical, Inc.NDACurrent
59148-011ABILIFYARIPIPRAZOLEOtsuka America Pharmaceutical, Inc.NDACurrent
59148-011ABILIFYARIPIPRAZOLEOtsuka America Pharmaceutical, Inc.NDACurrent
59148-011ABILIFYARIPIPRAZOLEOtsuka America Pharmaceutical, Inc.NDACurrent
59148-011ABILIFYARIPIPRAZOLEOtsuka America Pharmaceutical, Inc.NDACurrent
59148-011ABILIFYARIPIPRAZOLEOtsuka America Pharmaceutical, Inc.NDACurrent
59148-011ABILIFYARIPIPRAZOLEOtsuka America Pharmaceutical, Inc.NDACurrent
59148-011ABILIFYARIPIPRAZOLEOtsuka America Pharmaceutical, Inc.NDACurrent
59148-011ABILIFYARIPIPRAZOLEOtsuka America Pharmaceutical, Inc.NDACurrent
63629-3387ABILIFYARIPIPRAZOLEBryant Ranch PrepackNDACurrent
63629-3387ABILIFYARIPIPRAZOLEBryant Ranch PrepackNDACurrent
64725-0006ABILIFYARIPIPRAZOLETYA PharmaceuticalsNDACurrent
64725-0007ABILIFYARIPIPRAZOLETYA PharmaceuticalsNDACurrent
64725-0009ABILIFYARIPIPRAZOLETYA PharmaceuticalsNDACurrent
64725-8000ABILIFYARIPIPRAZOLETYA PharmaceuticalsNDACurrent
68151-4461ABILIFYARIPIPRAZOLECarilion Materials ManagementNDACurrent
68151-4982ABILIFYARIPIPRAZOLECarilion Materials ManagementNDACurrent
68151-5121ABILIFYARIPIPRAZOLECarilion Materials ManagementNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
81133SUPPL 2025-02-07
81132SUPPL 2025-02-07
81025SUPPL 2025-02-05
81024SUPPL 2025-02-05
81023SUPPL 2025-02-05
72780SUPPL2022-12-05
72779SUPPL2022-12-05
72756SUPPL2022-12-01
61819SUPPL2020-02-06
61818SUPPL2020-02-06
61817SUPPL2020-02-06
61816SUPPL2020-02-06
61792SUPPL2020-02-06
61791SUPPL2020-02-06
59634SUPPL2019-08-08
59633SUPPL2019-08-08
59622SUPPL2019-08-08
47424SUPPL2017-03-02
47330SUPPL2017-02-24
45787SUPPL2016-11-02
45238SUPPL2016-08-18
45086SUPPL2016-08-18
21657SUPPL2016-07-28
21656SUPPL2016-04-20
15466SUPPL2016-01-22
27780SUPPL2016-01-20
36925SUPPL2014-12-15
27779SUPPL2014-12-15
27777SUPPL2014-07-11
42164SUPPL2014-06-16
15464SUPPL2014-06-10
15465SUPPL2013-08-09
21654SUPPL2013-08-06
27778SUPPL2013-08-05
21653SUPPL2013-05-10
42160SUPPL2012-03-14
27776SUPPL2012-02-27
36924SUPPL2012-02-24
42163SUPPL2012-01-27
42162SUPPL2012-01-27
42161SUPPL2012-01-27
44122ORIG2011-12-22
5371SUPPL2011-03-08
15463SUPPL2011-03-07
36921SUPPL2011-02-24
5369SUPPL2011-02-18
5370SUPPL2010-12-07
36923SUPPL2010-12-03
27775SUPPL2010-12-03
36922SUPPL2010-12-02
5368SUPPL2009-11-27
15462SUPPL2009-11-23
24197SUPPL2009-08-20
21655SUPPL2009-08-20
27774SUPPL2009-07-24
36920SUPPL2009-07-23
15461SUPPL2008-08-26
5367SUPPL2008-08-19
24200SUPPL2008-07-17
24199SUPPL2008-07-17
24198SUPPL2008-07-17
27773SUPPL2008-05-14
27772SUPPL2008-05-14
5364SUPPL2008-05-14
5366SUPPL2008-03-07
5365SUPPL2008-02-29
15460SUPPL2008-02-28
27771SUPPL2007-11-19
15459SUPPL2007-11-19
27770SUPPL2007-11-08
36919SUPPL2007-11-07
5363SUPPL2007-10-04
36918SUPPL2007-09-26
42159SUPPL2007-09-24
21652SUPPL2007-09-24
36916SUPPL2006-10-23
27769SUPPL2006-10-23
36917SUPPL2006-09-20
5362SUPPL2006-09-20
36915SUPPL2006-02-22
27768SUPPL2006-02-22
36914SUPPL2005-06-23
27766SUPPL2005-06-23
27767SUPPL2005-03-03
27765SUPPL2005-03-03
15458SUPPL2005-03-03
15456SUPPL2005-03-03
27764SUPPL2004-10-04
15455SUPPL2004-10-04
15457SUPPL2004-05-03
5361SUPPL2004-04-20
15454SUPPL2003-09-09
5360SUPPL2003-09-09
42158ORIG2003-03-07
51237SUPPL2003-02-11
51236SUPPL2003-02-11
36913ORIG2002-11-15
27763ORIG2002-11-15
63504ORIG1900-01-01
63502SUPPL1900-01-01