FDA.reportPublic FDA data

Application 078614

Type
ANDA
Sponsor
SUN PHARMA GLOBAL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ARIPIPRAZOLEARIPIPRAZOLETABLET; ORAL5MGNoNo
002ARIPIPRAZOLEARIPIPRAZOLETABLET; ORAL10MGNoNo
003ARIPIPRAZOLEARIPIPRAZOLETABLET; ORAL15MGNoNo
004ARIPIPRAZOLEARIPIPRAZOLETABLET; ORAL20MGNoNo
005ARIPIPRAZOLEARIPIPRAZOLETABLET; ORAL30MGNoNo

Source provenance: Browse the complete Orange Book source catalog.

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 4 of 7 · 121 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Abilify AsimtufiiARIPIPRAZOLEOtsuka America Pharmaceutical, Incda4c07fd-1130-4341-bb44-63acfa4162be2025-04-04Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ARIPIPRAZOLE
aripiprazoleARIPIPRAZOLETorrent Pharmaceuticals Limited3988e66f-339c-451e-9f8a-9d0c0a2a381b2025-03-28Boxed warning, Warnings, Adverse reactionsName fallback
brand name: aripiprazole
generic name: ARIPIPRAZOLE
AripiprazoleARIPIPRAZOLEMacleods Pharmaceuticals Limitedab4245a1-71f7-45be-a2ef-b0636ed3cc202025-03-24Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Aripiprazole
generic name: ARIPIPRAZOLE
AripiprazoleARIPIPRAZOLEAmneal Pharmaceuticals LLC7f272100-e02f-4a16-bb39-a2bf844db4f92025-02-25Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Aripiprazole
generic name: ARIPIPRAZOLE
AripiprazoleARIPIPRAZOLEAmneal Pharmaceuticals LLC06dda03f-8481-46d6-af02-4f51e1a3a0652025-02-20Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Aripiprazole
generic name: ARIPIPRAZOLE
AripiprazoleARIPIPRAZOLEUnichem Pharmaceuticals (USA), Inc.349b8a7b-5ada-4f5c-a269-a86806c6b5202025-02-20Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Aripiprazole
generic name: ARIPIPRAZOLE
AripiprazoleARIPIPRAZOLE ORALCamber Pharmaceuticals, Inc.da47ad78-e62c-4bf3-9b53-d8cc246bcfb62025-02-19Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Aripiprazole
AripiprazoleARIPIPRAZOLEAlembic Pharmaceuticals Inc.de2dc5fd-ecb4-4445-9cfb-10e64fe3269d2025-02-19Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Aripiprazole
generic name: ARIPIPRAZOLE
OPIPZAARIPIPRAZOLECarwin Pharmaceutical Associates, LLCb47ede68-8942-4432-af7e-57afc14b2ba42025-01-30Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ARIPIPRAZOLE
ABILIFYARIPIPRAZOLEOtsuka America Pharmaceutical, Inc.c040bd1d-45b7-49f2-93ea-aed7220b30ac2025-01-29Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ARIPIPRAZOLE
AripiprazoleARIPIPRAZOLELannett Company, Inc.e7292c4c-e332-4ed4-9086-f130d223b6ae2025-01-24Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Aripiprazole
generic name: ARIPIPRAZOLE
AripiprazoleARIPIPRAZOLEDirect_Rxf823bc23-27f3-2397-e053-6294a90a365a2025-01-22Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Aripiprazole
generic name: ARIPIPRAZOLE
AripiprazoleARIPIPRAZOLEDirect_Rxf81d9b82-5879-3c0a-e053-6294a90ac23e2025-01-22Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Aripiprazole
generic name: ARIPIPRAZOLE
AripiprazoleARIPIPRAZOLEDirect_Rxfacdb9a9-612f-e59a-e053-6394a90a1fa72025-01-22Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Aripiprazole
generic name: ARIPIPRAZOLE
AripiprazoleARIPIPRAZOLEDirect_Rxfcea91c3-e428-8991-e053-6394a90a099d2025-01-22Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Aripiprazole
generic name: ARIPIPRAZOLE
AripiprazoleARIPIPRAZOLEBionpharma Inc.720bc395-777d-4e5d-9571-aad5827dbf6d2025-01-19Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Aripiprazole
generic name: ARIPIPRAZOLE
AripiprazoleARIPIPRAZOLEViona Pharmaceuticals Inc.73c5e380-b7b1-4362-a827-71881574ff482025-01-16Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Aripiprazole
generic name: ARIPIPRAZOLE
AripiprazoleARIPIPRAZOLEPreferred Pharmaceuticals Inc.34127431-6ad7-402f-bc22-1429c55d921c2025-01-03Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Aripiprazole
generic name: ARIPIPRAZOLE
AripiprazoleARIPIPRAZOLEPreferred Pharmaceuticals, Inc.4894031e-639e-49d8-927a-76d684bf66552025-01-03Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Aripiprazole
generic name: ARIPIPRAZOLE
aripiprazoleARIPIPRAZOLEPreferred Pharmaceuticals Inc.faa3032b-d9a1-45dd-88be-abb432223f132025-01-03Boxed warning, Warnings, Adverse reactionsName fallback
brand name: aripiprazole
generic name: ARIPIPRAZOLE

Reported adverse events (FAERS/openFDA)#

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