FDA.reportPublic FDA data

Application 021866

Type
NDA
Sponsor
OTSUKA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ABILIFYARIPIPRAZOLEINJECTABLE;INTRAMUSCULAR9.75MG/1.3ML (7.5MG/ML)NoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021866-001ABILIFYARIPIPRAZOLE9.75MG/1.3ML (7.5MG/ML)INJECTABLE / INTRAMUSCULAR2006-09-20

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N021866-001ABILIFY9.75MG/1.3ML (7.5MG/ML)INJECTABLE / INTRAMUSCULAR2006-09-20a50c72e98297…

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. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 6 · 113 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AripiprazoleARIPIPRAZOLEREMEDYREPACK INC.bc3fde41-2f24-44e2-815d-15fe55bd68b32026-07-30Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ARIPIPRAZOLE
AripiprazoleARIPIPRAZOLEREMEDYREPACK INC.506fa28f-6f98-4632-bce8-72a9cb507c902026-07-29Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ARIPIPRAZOLE
AripiprazoleARIPIPRAZOLEREMEDYREPACK INC.f713c38e-cc49-4243-96b9-32d5dbbcf9cb2026-07-29Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ARIPIPRAZOLE
aripiprazoleARIPIPRAZOLEREMEDYREPACK INC.1ad7d167-1235-4c5c-8159-da8972240ede2026-07-27Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ARIPIPRAZOLE
AripiprazoleARIPIPRAZOLEREMEDYREPACK INC.119e3387-39a2-4fe5-904b-c2d008425c0a2026-07-22Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ARIPIPRAZOLE
AripiprazoleARIPIPRAZOLEREMEDYREPACK INC.99747897-22fe-4bee-9942-6349c0c8f6b02026-07-17Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ARIPIPRAZOLE
AripiprazoleARIPIPRAZOLECoupler LLC56439ef6-a07e-34c9-e063-6294a90a77c32026-07-10Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ARIPIPRAZOLE
AripiprazoleARIPIPRAZOLECoupler LLC55f3a705-9412-0f88-e063-6294a90a2b532026-07-06Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ARIPIPRAZOLE
AripiprazoleARIPIPRAZOLECoupler LLC55f446b0-caa2-aca8-e063-6294a90af4412026-07-06Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ARIPIPRAZOLE
AripiprazoleARIPIPRAZOLEREMEDYREPACK INC.a1191a90-eb83-4a59-948c-b9774d2c83a52026-07-02Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ARIPIPRAZOLE
AripiprazoleARIPIPRAZOLEBryant Ranch Prepack69af5199-f872-4298-8d09-035e2127d3d42026-06-29Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ARIPIPRAZOLE
AripiprazoleARIPIPRAZOLEUnit Dose Solutions, Inc.535f4fbd-b6a7-7611-e063-6294a90a5c432026-06-03Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ARIPIPRAZOLE
AripiprazoleARIPIPRAZOLECoupler LLC52cc86ba-2c4f-1aba-e063-6294a90a844e2026-05-27Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ARIPIPRAZOLE
AripiprazoleARIPIPRAZOLECoupler LLC52bbfc8f-fa17-839e-e063-6394a90a63162026-05-26Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ARIPIPRAZOLE
AripiprazoleARIPIPRAZOLEMajor Pharmaceuticals573c6bb6-941f-4413-8c23-8260253858642026-05-21Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ARIPIPRAZOLE
aripiprazoleARIPIPRAZOLEREMEDYREPACK INC.9b695d4b-3794-4b89-8575-6feb83697ccc2026-05-18Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ARIPIPRAZOLE
AripiprazoleARIPIPRAZOLEBryant Ranch Prepackc092a736-16e2-4dd0-8769-cb766a62f4d92026-05-13Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ARIPIPRAZOLE
AripiprazoleARIPIPRAZOLECoupler LLC512874e6-6d00-2623-e063-6394a90aa4bc2026-05-06Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ARIPIPRAZOLE
AripiprazoleARIPIPRAZOLEREMEDYREPACK INC.6f580e75-61ab-4c7b-bb3f-f027a9603f842026-04-03Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ARIPIPRAZOLE
ABILIFY MAINTENAARIPIPRAZOLEOtsuka America Pharmaceutical, Inc.ee49f3b1-1650-47ff-9fb1-ea53fe0b92b62026-03-24Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ARIPIPRAZOLE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
59148-016ABILIFYARIPIPRAZOLEOtsuka America Pharmaceutical, Inc.NDACurrent
59148-016ABILIFYARIPIPRAZOLEOtsuka America Pharmaceutical, Inc.NDACurrent
59148-016ABILIFYARIPIPRAZOLEOtsuka America Pharmaceutical, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
61831SUPPL2020-02-06
61830SUPPL2020-02-06
61829SUPPL2020-02-06
61828SUPPL2020-02-06
61801SUPPL2020-02-06
61800SUPPL2020-02-06
59640SUPPL2019-08-08
59639SUPPL2019-08-08
59625SUPPL2019-08-08
47427SUPPL2017-03-02
47327SUPPL2017-02-24
45052SUPPL2016-08-23
45053SUPPL2016-08-18
37792SUPPL2016-01-22
6342SUPPL2016-01-20
16485SUPPL2014-12-15
6341SUPPL2014-12-15
6339SUPPL2014-07-11
37790SUPPL2014-06-10
37791SUPPL2013-08-09
6340SUPPL2013-08-05
28743SUPPL2012-02-27
37789SUPPL2012-02-24
42333SUPPL2012-01-27
42332SUPPL2012-01-27
21847SUPPL2012-01-27
44158ORIG2011-12-22
28742SUPPL2011-03-08
37788SUPPL2011-03-07
37786SUPPL2011-02-24
6337SUPPL2011-02-18
28741SUPPL2010-12-07
16484SUPPL2010-12-03
6338SUPPL2010-12-03
37787SUPPL2010-12-02
28740SUPPL2010-02-17
28733SUPPL2010-02-14
16481SUPPL2010-02-14
28739SUPPL2009-07-24
37785SUPPL2009-07-23
37784SUPPL2008-08-26
28738SUPPL2008-08-19
24222ORIG2008-08-12
21846ORIG2008-08-11
44655SUPPL2008-07-17
44654SUPPL2008-07-17
44653SUPPL2008-07-17
28736SUPPL2008-05-14
28735SUPPL2008-05-14
6335SUPPL2008-05-14
28737SUPPL2008-03-07
6336SUPPL2008-02-29
16483SUPPL2008-02-28
37783SUPPL2007-11-19
28734SUPPL2007-11-19
6334SUPPL2007-11-08
16482SUPPL2007-11-07
28732SUPPL2007-10-04
16480SUPPL2007-09-26
6333ORIG2006-09-25
37782ORIG2006-09-21
51608SUPPL1900-01-01