aripiprazole Injection

Brand(s)
Abilify
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Otsuka America Pharmaceutical, Inc. (2015-07-30)
Oldest Current Product
2006-09-20
License(s)
NDA
RxNORM
INJECTION\ARIPIPRAZOLE
FDAOB
INTRAMUSCULAR\FOR SUSPENSION, EXTENDED RELEASE\ARIPIPRAZOLE
INTRAMUSCULAR\INJECTION\ARIPIPRAZOLE
SPL Active
INTRAMUSCULAR\INJECTION, SOLUTION\ARIPIPRAZOLE
SPL Moiety
INTRAMUSCULAR\INJECTION, SOLUTION\ARIPIPRAZOLE

product(s) by strength(s)

aripiprazole 300 mg injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)dose formapplicationspl
1591480018AbilifyNDAOtsuka America Pharmaceutical, Inc.2013-02-28ARIPIPRAZOLEKITNDA202971ee49f3b1-1650-47ff-9fb1-ea53fe0b92b6

aripiprazole 400 mg injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)dose formapplicationspl
1591480019AbilifyNDAOtsuka America Pharmaceutical, Inc.2013-02-28ARIPIPRAZOLEKITNDA202971ee49f3b1-1650-47ff-9fb1-ea53fe0b92b6

1.3 ml aripiprazole 7.5 mg/ml injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1591480016AbilifyNDAOtsuka America Pharmaceutical, Inc.2006-09-20ARIPIPRAZOLEINTRAMUSCULARINJECTION, SOLUTIONNDA021866c040bd1d-45b7-49f2-93ea-aed7220b30ac

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA021866ABILIFYOTSUKA PHARMACEUTICAL CO LTD2006-09-20p7550445, SUBSTANCE
p7115587, TREATMENT OF SCHIZOPHRENIA, SUBSTANCE
p5006528, TREATMENT OF SCHIZOPHRENIA/ ADMINISTRATION OF ARIPIPRAZOLE BY INJECTION, SUBSTANCE
ORPHAN DRUG EXCLUSIVITY [2021-12-12]
TREATMENT OF PEDIATRIC PATIENTS WITH TOURETTE'S DISORDER (6-18 YEARS) [2017-12-12]
LABELING REVISIONS RESULTING FROM A MAINTENANCE TRIAL IN PEDIATRIC PATIENTS WITH IRRITABILITY ASSOCIATED WITH AUTISTIC DISORDER [2017-06-09]
NDA021866_001
2NDA202971ABILIFY MAINTENA KITOTSUKA PHARMACEUTICAL CO LTD2013-02-28p8338428, TREATMENT OF SCHIZOPHRENIA/ USE OF ARIPIPRAZOLE IN EXTENDED RELEASE INJECTABLE SUSPENSION IN TREATING ACUTE EPISODES OF SCHIZOPHRENIA, SUBSTANCE
p8030313, TREATMENT OF SCHIZOPHRENIA/ TREATMENT OF SCHIZOPHRENIA
p8759351, USE OF ARIPIPRAZOLE IN EXTENDED RELEASE INJECTABLE SUSPENSION IN TREATING ACUTE EPISODES OF SCHIZOPHRENIA/ USE OF ARIPIPRAZOLE IN EXTENDED RELEASE INJECTABLE SUSPENSION, SUBSTANCE
p8722679, SUBSTANCE
p7807680, SUBSTANCE
p9089567, TREATMENT OF SCHIZOPHRENIA
p5006528, TREATMENT OF SCHIZOPHRENIA/ TREATMENT OF SCHIZOPHRENIA, SUBSTANCE
p8993761
p8399469
p8338427, TREATMENT OF SCHIZOPHRENIA/ USE OF ARIPIPRAZOLE IN EXTENDED RELEASE INJECTABLE SUSPENSION IN TREATING ACUTE EPISODES OF SCHIZOPHRENIA, SUBSTANCE
ADDITION OF THE RESULTS OF A CONTROLLED CLINICAL STUDY TREATING ADULT PATIENTS WITH SCHIZOPHRENIA EXPERIENCING AN ACUTE RELAPSE [2017-12-05]
NEW DOSAGE FORM [2016-02-28]
NDA202971_001, NDA202971_002, NDA202971_003, NDA202971_004

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA021866_001RXARIPIPRAZOLE (9.75MG/1.3ML)INTRAMUSCULARINJECTIONTrue2006-09-20ABILIFY
2NDA202971_001RXARIPIPRAZOLE (300MG/VIAL)INTRAMUSCULARFOR SUSPENSION, EXTENDED RELEASEFalse2013-02-28ABILIFY MAINTENA KIT
3NDA202971_002RXARIPIPRAZOLE (400MG/VIAL)INTRAMUSCULARFOR SUSPENSION, EXTENDED RELEASETrue2013-02-28ABILIFY MAINTENA KIT
4NDA202971_003RXARIPIPRAZOLE (300MG)INTRAMUSCULARFOR SUSPENSION, EXTENDED RELEASEFalse2014-09-29ABILIFY MAINTENA KIT
5NDA202971_004RXARIPIPRAZOLE (400MG)INTRAMUSCULARFOR SUSPENSION, EXTENDED RELEASEFalse2014-09-29ABILIFY MAINTENA KIT

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p5006528 (view patent)2014-10-20NDA021866, NDA202971, NDA021436, NDA021713, NDA021729aripiprazole Disintegrating Oral Tablet
aripiprazole Oral Solution
aripiprazole Oral Tablet
2p7115587 (view patent)2024-07-21NDA021866
3p7550445 (view patent)2024-07-21NDA021866
4p7807680 (view patent)2024-10-19NDA202971
5p8030313 (view patent)2024-10-19NDA202971
6p8338427 (view patent)2025-03-15NDA202971
7p8338428 (view patent)2023-08-06NDA202971
8p8399469 (view patent)2025-06-29NDA202971
9p8722679 (view patent)2024-10-19NDA202971
10p8759351 (view patent)2023-08-06NDA202971
11p8993761 (view patent)2022-09-25NDA202971
12p9089567 (view patent)2022-01-28NDA202971, NDA021436, NDA021729aripiprazole Disintegrating Oral Tablet
aripiprazole Oral Tablet

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
1c040bd1d-45b7-49f2-93ea-aed7220b30ac (view SPL)These highlights do not include all the information needed to use ABILIFY safely and effectively. See full prescribing information for ABILIFY.ABILIFY (aripiprazole) TabletsABILIFY DISCMELT (aripiprazole) Orally Disintegrating TabletsABILIFY (aripiprazole) Oral SolutionABILIFY (aripiprazole) Injection FOR INTRAMUSCULAR USE ONLY Initial U.S. Approval: 2002prescriptionHuman PrescriptionOtsuka America Pharmaceutical, Inc.2014-07-0356591480016, 591480006, 591480007, 591480008, 591480009, 591480010, 591480011, 591480013, 591480640, 591480641aripiprazole Disintegrating Oral Tablet
aripiprazole Oral Solution
aripiprazole Oral Tablet
2ee49f3b1-1650-47ff-9fb1-ea53fe0b92b6 (view SPL)These highlights do not include all the information needed to use ABILIFY MAINTENA safely and effectively. See full prescribing information for ABILIFY MAINTENA. ABILIFY MAINTENA (aripiprazole) for extended-release injectable suspension, for intramuscular useInitial U.S. Approval: 2002prescriptionHuman PrescriptionOtsuka America Pharmaceutical, Inc.MANUFACTURE2015-07-309591480018, 591480019, 591480045, 591480072

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