FDA.reportPublic FDA data

Application 021713

Type
NDA
Sponsor
OTSUKA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ABILIFYARIPIPRAZOLESOLUTION;ORAL1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo

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
N021713-001ABILIFYARIPIPRAZOLE1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / ORALRLD2004-12-10

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N021713-00187593502027-03-02U-15292014-07-22

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 22:54:322026-06N021713-001ABILIFY1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / ORALRLD2004-12-10a50c72e98297…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-01 22:54:322026-06N021713-00187593502027-03-02U-15292014-07-22a50c72e98297…

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
59148-013ABILIFYARIPIPRAZOLEOtsuka America Pharmaceutical, Inc.NDACurrent
59148-013ABILIFYARIPIPRAZOLEOtsuka America Pharmaceutical, Inc.NDACurrent
59148-013ABILIFYARIPIPRAZOLEOtsuka America Pharmaceutical, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
61823SUPPL2020-02-06
61822SUPPL2020-02-06
61821SUPPL2020-02-06
61820SUPPL2020-02-06
61797SUPPL2020-02-06
61796SUPPL2020-02-06
59636SUPPL2019-08-08
59635SUPPL2019-08-08
59623SUPPL2019-08-08
47425SUPPL2017-03-02
47329SUPPL2017-02-24
45103SUPPL2016-08-23
45148SUPPL2016-08-18
16247SUPPL2016-01-22
6037SUPPL2016-01-20
37510SUPPL2014-12-15
28449SUPPL2014-12-15
28447SUPPL2014-07-11
16245SUPPL2014-06-10
16246SUPPL2013-08-09
28448SUPPL2013-08-05
6036SUPPL2012-02-27
16244SUPPL2012-02-24
42281SUPPL2012-01-27
21787SUPPL2012-01-27
21786SUPPL2012-01-27
44147ORIG2011-12-22
6035SUPPL2011-03-08
16243SUPPL2011-03-07
37507SUPPL2011-02-24
6033SUPPL2011-02-18
6034SUPPL2010-12-07
37509SUPPL2010-12-03
28446SUPPL2010-12-03
37508SUPPL2010-12-02
28445SUPPL2009-07-24
37506SUPPL2009-07-23
37505SUPPL2008-08-26
28444SUPPL2008-08-19
44644SUPPL2008-07-17
24210SUPPL2008-07-17
24209SUPPL2008-07-17
28442SUPPL2008-05-14
28441SUPPL2008-05-14
28440SUPPL2008-05-14
28443SUPPL2008-03-07
6032SUPPL2008-02-29
16242SUPPL2008-02-28
28439SUPPL2007-11-19
16241SUPPL2007-11-19
28438SUPPL2007-11-08
37504SUPPL2007-11-07
28437SUPPL2007-10-04
16240SUPPL2007-09-26
37502SUPPL2006-10-23
28435SUPPL2006-10-23
42280ORIG2006-09-27
37503SUPPL2006-09-20
28436SUPPL2006-09-20
16239SUPPL2006-02-22
6031SUPPL2006-02-22
37501SUPPL2005-06-23
6030SUPPL2005-06-23
16238SUPPL2005-03-03
6029SUPPL2005-03-03
37500ORIG2004-12-10
28434ORIG2004-12-10
51606SUPPL1900-01-01