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 43.

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.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N021866-001ABILIFY9.75MG/1.3ML (7.5MG/ML)INJECTABLE / INTRAMUSCULAR2006-09-2084e616aacf4f…
2026-08-18 06:07:402026-07N021866-001ABILIFY9.75MG/1.3ML (7.5MG/ML)INJECTABLE / INTRAMUSCULAR2006-09-20caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021866-001ABILIFY9.75MG/1.3ML (7.5MG/ML)INJECTABLE / INTRAMUSCULAR2006-09-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021866-001ABILIFY9.75MG/1.3ML (7.5MG/ML)INJECTABLE / INTRAMUSCULAR2006-09-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08N021866-001ABILIFY9.75MG/1.3ML (7.5MG/ML)INJECTABLE / INTRAMUSCULAR2006-09-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021866-001ABILIFY9.75MG/1.3ML (7.5MG/ML)INJECTABLE / INTRAMUSCULAR2006-09-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021866-001ABILIFY9.75MG/1.3ML (7.5MG/ML)INJECTABLE / INTRAMUSCULAR2006-09-20b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021866-001ABILIFY9.75MG/1.3ML (7.5MG/ML)INJECTABLE / INTRAMUSCULAR2006-09-2003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021866-001ABILIFY9.75MG/1.3ML (7.5MG/ML)INJECTABLE / INTRAMUSCULAR2006-09-202680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021866-001ABILIFY9.75MG/1.3ML (7.5MG/ML)INJECTABLE / INTRAMUSCULAR2006-09-205bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021866-001ABILIFY9.75MG/1.3ML (7.5MG/ML)INJECTABLE / INTRAMUSCULAR2006-09-20d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021866-001ABILIFY9.75MG/1.3ML (7.5MG/ML)INJECTABLE / INTRAMUSCULAR2006-09-20d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021866-001ABILIFY9.75MG/1.3ML (7.5MG/ML)INJECTABLE / INTRAMUSCULAR2006-09-2079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021866-001ABILIFY9.75MG/1.3ML (7.5MG/ML)INJECTABLE / INTRAMUSCULAR2006-09-20301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021866-001ABILIFY9.75MG/1.3ML (7.5MG/ML)INJECTABLE / INTRAMUSCULAR2006-09-201e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021866-001ABILIFY9.75MG/1.3ML (7.5MG/ML)INJECTABLE / INTRAMUSCULAR2006-09-208072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021866-001ABILIFY9.75MG/1.3ML (7.5MG/ML)INJECTABLE / INTRAMUSCULAR2006-09-205c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021866-001ABILIFY9.75MG/1.3ML (7.5MG/ML)INJECTABLE / INTRAMUSCULAR2006-09-205d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021866-001ABILIFY9.75MG/1.3ML (7.5MG/ML)INJECTABLE / INTRAMUSCULAR2006-09-204b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021866-001ABILIFY9.75MG/1.3ML (7.5MG/ML)INJECTABLE / INTRAMUSCULAR2006-09-2074a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021866-001ABILIFY9.75MG/1.3ML (7.5MG/ML)INJECTABLE / INTRAMUSCULAR2006-09-20bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021866-001ABILIFY9.75MG/1.3ML (7.5MG/ML)INJECTABLE / INTRAMUSCULAR2006-09-20782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021866-001ABILIFY9.75MG/1.3ML (7.5MG/ML)INJECTABLE / INTRAMUSCULAR2006-09-2087673890dc5c…
2021-03-12 10:30 UTC2021-03N021866-001ABILIFY9.75MG/1.3ML (7.5MG/ML)INJECTABLE / INTRAMUSCULAR2006-09-205aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021866-001ABILIFY9.75MG/1.3ML (7.5MG/ML)INJECTABLE / INTRAMUSCULAR2006-09-208869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021866-001ABILIFY9.75MG/1.3ML (7.5MG/ML)INJECTABLE / INTRAMUSCULAR2006-09-20c0c555d07b60…
2019-12-14 00:12 UTC2019-12N021866-001ABILIFY9.75MG/1.3ML (7.5MG/ML)INJECTABLE / INTRAMUSCULAR2006-09-203f01610625f2…
2019-09-15 20:21 UTC2019-09N021866-001ABILIFY9.75MG/1.3ML (7.5MG/ML)INJECTABLE / INTRAMUSCULAR2006-09-20b00525d2431f…
2019-07-19 19:46 UTC2019-07N021866-001ABILIFY9.75MG/1.3ML (7.5MG/ML)INJECTABLE / INTRAMUSCULAR2006-09-20ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N021866-001ABILIFY9.75MG/1.3ML (7.5MG/ML)INJECTABLE / INTRAMUSCULAR2006-09-206a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N021866-001ABILIFY9.75MG/1.3ML (7.5MG/ML)INJECTABLE / INTRAMUSCULAR2006-09-201c564ffb4f44…
2023-12-20 04:57 UTC2023-12N021866-001ABILIFY9.75MG/1.3ML (7.5MG/ML)INJECTABLE / INTRAMUSCULAR2006-09-20ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N021866-001ABILIFY9.75MG/1.3ML (7.5MG/ML)INJECTABLE / INTRAMUSCULAR2006-09-20a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N021866-001ABILIFY9.75MG/1.3ML (7.5MG/ML)INJECTABLE / INTRAMUSCULAR2006-09-209b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N021866-001ABILIFY9.75MG/1.3ML (7.5MG/ML)INJECTABLE / INTRAMUSCULAR2006-09-20a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N021866-001ABILIFY9.75MG/1.3ML (7.5MG/ML)INJECTABLE / INTRAMUSCULAR2006-09-203f0d92c62455…
2023-05-13 08:27 UTC2023-05N021866-001ABILIFY9.75MG/1.3ML (7.5MG/ML)INJECTABLE / INTRAMUSCULAR2006-09-20053a50430f4f…
2023-01-26 05:58 UTC2023-01N021866-001ABILIFY9.75MG/1.3ML (7.5MG/ML)INJECTABLE / INTRAMUSCULAR2006-09-203bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N021866-001ABILIFY9.75MG/1.3ML (7.5MG/ML)INJECTABLE / INTRAMUSCULAR2006-09-203a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N021866-001ABILIFY9.75MG/1.3ML (7.5MG/ML)INJECTABLE / INTRAMUSCULAR2006-09-20f41ea6bd6efb…

Observed Orange Book patent history#

Patent history page 1 of 4 · 150 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021866-00171155872024-07-21U-764Drug product31067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021866-00175504452024-07-21Drug product31067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021866-0017115587*PED2025-01-21Pediatric extension31067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021866-0017550445*PED2025-01-21Pediatric extension31067a03dcf5…
2025-08-23 18:47 UTC2025-08N021866-0017115587*PED2025-01-21Pediatric extension6a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021866-0017550445*PED2025-01-21Pediatric extension6a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021866-0017115587*PED2025-01-21Pediatric extensionfd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021866-0017550445*PED2025-01-21Pediatric extensionfd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021866-0017115587*PED2025-01-21Pediatric extensionb8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021866-0017550445*PED2025-01-21Pediatric extensionb8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021866-00171155872024-07-21U-764Drug product03ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021866-00175504452024-07-21Drug product03ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021866-0017115587*PED2025-01-21Pediatric extension03ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021866-0017550445*PED2025-01-21Pediatric extension03ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021866-00171155872024-07-21U-764Drug product2680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021866-00175504452024-07-21Drug product2680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021866-0017115587*PED2025-01-21Pediatric extension2680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021866-0017550445*PED2025-01-21Pediatric extension2680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021866-00171155872024-07-21U-764Drug product5bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021866-00175504452024-07-21Drug product5bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021866-0017115587*PED2025-01-21Pediatric extension5bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021866-0017550445*PED2025-01-21Pediatric extension5bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021866-00171155872024-07-21U-764Drug productd8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021866-00175504452024-07-21Drug productd8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021866-0017115587*PED2025-01-21Pediatric extensiond8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021866-0017550445*PED2025-01-21Pediatric extensiond8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021866-00171155872024-07-21U-764Drug productd06236e962d9…
2024-10-29 15:01 UTC2024-10N021866-00175504452024-07-21Drug productd06236e962d9…
2024-10-29 15:01 UTC2024-10N021866-0017115587*PED2025-01-21Pediatric extensiond06236e962d9…
2024-10-29 15:01 UTC2024-10N021866-0017550445*PED2025-01-21Pediatric extensiond06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021866-00171155872024-07-21U-764Drug product79d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021866-00175504452024-07-21Drug product79d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021866-0017115587*PED2025-01-21Pediatric extension79d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021866-0017550445*PED2025-01-21Pediatric extension79d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021866-00171155872024-07-21U-764Drug product301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021866-00175504452024-07-21Drug product301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021866-0017115587*PED2025-01-21Pediatric extension301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021866-0017550445*PED2025-01-21Pediatric extension301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021866-00171155872024-07-21U-764Drug product1e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021866-00175504452024-07-21Drug product1e350fbaab3a…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2019-12-13 00:20 UTC2019-12N021866-001ODE-802021-12-1274a2ff9319b5…
2021-12-28 21:50 UTC2021-12N021866-001ODE-802021-12-12782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021866-001ODE-802021-12-1287673890dc5c…
2021-03-12 10:30 UTC2021-03N021866-001ODE-802021-12-125aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021866-001ODE-802021-12-128869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021866-001ODE-802021-12-12c0c555d07b60…
2019-12-14 00:12 UTC2019-12N021866-001ODE-802021-12-123f01610625f2…
2019-09-15 20:21 UTC2019-09N021866-001ODE-802021-12-12b00525d2431f…
2019-07-19 19:46 UTC2019-07N021866-001ODE-802021-12-12ea99ee380514…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 6 of 6 · 116 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AripiprazoleARIPIPRAZOLENorthStar RxLLCf87dbfe4-5417-47c9-a97f-d246cfc100232023-08-30Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ARIPIPRAZOLE
AripiprazoleARIPIPRAZOLESQUARE PHARMACEUTICALS LIMITED0f9b1fd8-a648-45c9-8655-14de07439f342023-07-02Name fallback
generic name: ARIPIPRAZOLE
AripiprazoleARIPIPRAZOLEXLCare Pharmaceuticals, Inc.0a6fa113-6bb2-4f88-af07-ce0914c98ff22023-06-16Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ARIPIPRAZOLE
AripiprazoleARIPIPRAZOLEScieGen Pharmaceuticals Inca7d9d5d1-25ba-4f4e-a990-398c0bf09c7e2023-02-20Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ARIPIPRAZOLE
AripiprazoleARIPIPRAZOLEAlembic Pharmaceuticals Limited4f1691a8-724e-430d-9bab-27b59ef9bd4e2023-01-27Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ARIPIPRAZOLE
AripiprazoleARIPIPRAZOLEAlembic Pharmaceuticals Limited793fc904-2f11-4f97-a0ac-4d6910cac0f92023-01-27Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ARIPIPRAZOLE
AripiprazoleARIPIPRAZOLEXLCare Pharmaceuticals, Inc.b284b294-40a0-4ccd-b7b7-b61267cd4e762023-01-16Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ARIPIPRAZOLE
ARIPIPRAZOLEARIPIPRAZOLEA-S Medication Solutionsaaf7dc7e-04f3-442b-86d7-5f54d17d102c2022-09-12Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ARIPIPRAZOLE
AripiprazoleARIPIPRAZOLENCS HealthCare of KY, LLC dba Vangard Labs8da99c93-613e-4b78-9f91-3efc2dea194d2022-08-02Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ARIPIPRAZOLE
AripiprazoleARIPIPRAZOLEProficient Rx LP19a3c2f2-11eb-4ec9-ac38-134168bdf99c2022-08-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ARIPIPRAZOLE
AripiprazoleARIPIPRAZOLEProficient Rx LP11202c0a-7401-41c9-b1e7-d93739fcd36f2022-06-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ARIPIPRAZOLE
AripiprazoleARIPIPRAZOLEDr.Reddys Laboratories Inc0aa7e178-456a-4942-93aa-9ec18a58939f2020-06-16Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ARIPIPRAZOLE
AripiprazoleARIPIPRAZOLEScieGen Pharmaceuticals Inc95954ba3-e838-4dd7-aef1-c51ac6aff76b2020-05-06Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ARIPIPRAZOLE
AripiprazoleARIPIPRAZOLEProficient Rx LPdbdc8fbe-c75f-4f17-a2cd-9f23802dcc5d2019-11-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ARIPIPRAZOLE
AripiprazoleARIPIPRAZOLEExelan Pharmaceuticals, Inc.705190bf-9f9d-4183-a56b-4eeafeacde592018-12-28Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ARIPIPRAZOLE
ARIPIPRAZOLEARIPIPRAZOLECamber Pharmaceuticals, Inc.3718e585-06b9-40fd-a3eb-18b6497a42352017-08-08Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ARIPIPRAZOLE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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