FDA.reportPublic FDA data

Application 078612

Type
ANDA
Sponsor
BARR LABS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ARIPIPRAZOLEARIPIPRAZOLETABLET, ORALLY DISINTEGRATING; ORAL10MGNoNo
002ARIPIPRAZOLEARIPIPRAZOLETABLET, ORALLY DISINTEGRATING; ORAL15MGNoNo
003ARIPIPRAZOLEARIPIPRAZOLETABLET, ORALLY DISINTEGRATING; ORAL20MGNoNo
004ARIPIPRAZOLEARIPIPRAZOLETABLET; ORALLY DISINTEGRATING30MGNoNo

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 3 of 7 · 121 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ARIPIPRAZOLEARIPIPRAZOLEQUAGEN PHARMACEUTICALS LLCb12f1ff2-c0b5-47e7-8075-bf2ce79fdaf82025-12-22Boxed warning, Warnings, Adverse reactionsName fallback
brand name: ARIPIPRAZOLE
generic name: ARIPIPRAZOLE
AripiprazoleARIPIPRAZOLEQuallent Pharmaceuticals Health LLC0e0d42ad-f4c6-4e30-adc2-ab1d122428ec2025-12-04Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Aripiprazole
generic name: ARIPIPRAZOLE
AripiprazoleARIPIPRAZOLEAdvagen Pharma Ltd4537e26b-dcf8-4a78-ab7d-57359b1d21922025-12-02Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Aripiprazole
generic name: ARIPIPRAZOLE
AripiprazoleARIPIPRAZOLEDr.Reddys Laboratories Inc178f09f0-e08e-452b-b817-717c5c49e1102025-10-24Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Aripiprazole
generic name: ARIPIPRAZOLE
AripiprazoleARIPIPRAZOLENuCare Pharmaceuticals, Inc.414b7fd2-6a63-af39-e063-6394a90a00b82025-10-16Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Aripiprazole
generic name: ARIPIPRAZOLE
AripiprazoleARIPIPRAZOLEPD-Rx Pharmaceuticals, Inc.0cf6655e-d59a-4ebd-9698-195cad2adbd52025-10-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Aripiprazole
generic name: ARIPIPRAZOLE
AripiprazoleARIPIPRAZOLEAjanta Pharma USA Inc.d0f910b5-adef-4a93-9369-70f1ed5415032025-10-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Aripiprazole
generic name: ARIPIPRAZOLE
ARIPIPRAZOLEARIPIPRAZOLEAccord Healthcare, Inc.85cc7d25-414b-4b6f-a03a-48af908a16a12025-10-06Boxed warning, Warnings, Adverse reactionsName fallback
brand name: ARIPIPRAZOLE
generic name: ARIPIPRAZOLE
AripiprazoleARIPIPRAZOLEAscend Laboratories, LLCc7040fef-96a7-4429-9a8e-ec3ab17a80192025-10-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Aripiprazole
generic name: ARIPIPRAZOLE
AripiprazoleARIPIPRAZOLEAvPAK7df4c83e-13d8-25b1-57eb-08d26ba035652025-08-26Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Aripiprazole
generic name: ARIPIPRAZOLE
AripiprazoleARIPIPRAZOLENuCare Pharmaceuticals, Inc.3cf72cc6-ae43-bfd5-e063-6294a90a18b02025-08-22Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Aripiprazole
generic name: ARIPIPRAZOLE
AripiprazoleARIPIPRAZOLEAmerican Health Packaging80e079f0-faf5-4c0c-b1a8-9bc3cc2cde002025-08-13Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Aripiprazole
generic name: ARIPIPRAZOLE
aripiprazoleARIPIPRAZOLEProficient Rx LP2c2b0172-b186-4be4-a002-4a26adf120c62025-08-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: aripiprazole
generic name: ARIPIPRAZOLE
aripiprazoleARIPIPRAZOLEProficient Rx LPa3c0be94-c6c0-47e2-892f-c51f100fb3a32025-08-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: aripiprazole
generic name: ARIPIPRAZOLE
AripiprazoleARIPIPRAZOLEAlembic Pharmaceuticals Inc.a10a5427-58b1-42dd-964c-3f8c787705342025-06-25Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Aripiprazole
generic name: ARIPIPRAZOLE
AripiprazoleARIPIPRAZOLENuCare Pharmaceuticals,Inc.3726d102-dd9f-645e-e063-6294a90aeb9e2025-06-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Aripiprazole
generic name: ARIPIPRAZOLE
AripiprazoleARIPIPRAZOLEA-S Medication Solutionsa8edb057-18a3-446d-8af0-672c97933a882025-06-03Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Aripiprazole
generic name: ARIPIPRAZOLE
aripiprazoleARIPIPRAZOLEST. MARY'S MEDICAL PARK PHARMACY35a86989-862e-b0bb-e063-6394a90a7ec12025-05-21Boxed warning, Warnings, Adverse reactionsName fallback
brand name: aripiprazole
generic name: ARIPIPRAZOLE
AripiprazoleARIPIPRAZOLEChartwell RX, LLC1d27462e-45c7-4335-9092-84c340e06a2c2025-05-16Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Aripiprazole
generic name: ARIPIPRAZOLE
AripiprazoleARIPIPRAZOLEBryant Ranch Prepack385301f5-e59d-42d5-8544-aadf0ee0c9672025-04-29Boxed 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.