FDA.reportPublic FDA data

Application 216608

Type
ANDA
Sponsor
MYLAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ARIPIPRAZOLEARIPIPRAZOLEFOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR300MG/VIALNoNo
002ARIPIPRAZOLEARIPIPRAZOLEFOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR400MG/VIALNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A216608-001ARIPIPRAZOLEARIPIPRAZOLE300MG/VIALFOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR2024-12-03
A216608-002ARIPIPRAZOLEARIPIPRAZOLE400MG/VIALFOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR2024-12-03

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
2026-09-14 22:38:342026-08A216608-001ARIPIPRAZOLE300MG/VIALFOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR2024-12-0384e616aacf4f…
2026-09-14 22:38:342026-08A216608-002ARIPIPRAZOLE400MG/VIALFOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR2024-12-0384e616aacf4f…
2026-08-18 06:07:402026-07A216608-001ARIPIPRAZOLE300MG/VIALFOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR2024-12-03caaa826d4ba7…
2026-08-18 06:07:402026-07A216608-002ARIPIPRAZOLE400MG/VIALFOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR2024-12-03caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A216608-001ARIPIPRAZOLE300MG/VIALFOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR2024-12-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216608-002ARIPIPRAZOLE400MG/VIALFOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR2024-12-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216608-001ARIPIPRAZOLE300MG/VIALFOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR2024-12-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216608-002ARIPIPRAZOLE400MG/VIALFOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR2024-12-0331067a03dcf5…
2025-08-23 18:47 UTC2025-08A216608-001ARIPIPRAZOLE300MG/VIALFOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR2024-12-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A216608-002ARIPIPRAZOLE400MG/VIALFOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR2024-12-036a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216608-001ARIPIPRAZOLE300MG/VIALFOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR2024-12-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216608-002ARIPIPRAZOLE400MG/VIALFOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR2024-12-03fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216608-001ARIPIPRAZOLE300MG/VIALFOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR2024-12-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216608-002ARIPIPRAZOLE400MG/VIALFOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR2024-12-03b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216608-001ARIPIPRAZOLE300MG/VIALFOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULARAP2024-12-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216608-002ARIPIPRAZOLE400MG/VIALFOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULARAP2024-12-0303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216608-001ARIPIPRAZOLE300MG/VIALFOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULARAP2024-12-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216608-002ARIPIPRAZOLE400MG/VIALFOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULARAP2024-12-032680178bc6a6…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A216608-001ARIPIPRAZOLE300MG/VIALFOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR2024-12-03a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A216608-002ARIPIPRAZOLE400MG/VIALFOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR2024-12-03a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216608-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216608-002AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216608-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216608-002AP12680178bc6a6…

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 5 of 7 · 121 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AripiprazoleARIPIPRAZOLEPrefferred Pharmaceuticals Inc.fbb3ac69-8dba-42df-8d6d-ef3d79241edb2025-01-03Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Aripiprazole
generic name: ARIPIPRAZOLE
AripiprazoleARIPIPRAZOLENuCare Pharmaceuticals, Inc.27874fe2-3fd6-002d-e063-6294a90a4cd72024-11-22Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Aripiprazole
generic name: ARIPIPRAZOLE
AripiprazoleARIPIPRAZOLE ORALLY DISINTEGRATINGScieGen Pharmaceuticals Inc4bcfd5a7-bec7-4426-9314-17daaf715cad2024-11-13Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Aripiprazole
aripiprazoleARIPIPRAZOLEBryant Ranch Prepacke7b6a156-8001-441c-bfd3-bf8987a339e82024-10-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: aripiprazole
generic name: ARIPIPRAZOLE
aripiprazoleARIPIPRAZOLEBryant Ranch Prepackb62837db-1949-4dba-9e2f-714a9f136f5a2024-10-29Boxed warning, Warnings, Adverse reactionsName fallback
brand name: aripiprazole
generic name: ARIPIPRAZOLE
aripiprazoleARIPIPRAZOLEBryant Ranch Prepackd130836c-5f1c-4779-ac6c-6350752dc0152024-10-29Boxed warning, Warnings, Adverse reactionsName fallback
brand name: aripiprazole
generic name: ARIPIPRAZOLE
AripiprazoleARIPIPRAZOLENCS HealthCare of KY, LLC dba Vangard Labsd8183eaf-0093-4720-b8ed-20e5706975112024-10-25Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Aripiprazole
generic name: ARIPIPRAZOLE
AripiprazoleARIPIPRAZOLEA-S Medication Solutionsbf3cf835-4c4e-47cb-be9c-bcb7c2e11cbe2024-10-16Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Aripiprazole
generic name: ARIPIPRAZOLE
AripiprazoleARIPIPRAZOLEAurobindo Pharma Limitedfcabd777-dcb7-452c-821c-575a5991c90a2024-10-03Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Aripiprazole
generic name: ARIPIPRAZOLE
AripiprazoleARIPIPRAZOLEVistaPharm, LLC06529caf-698f-41da-81ec-d0ba5ab200d72024-09-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Aripiprazole
generic name: ARIPIPRAZOLE
AripiprazoleARIPIPRAZOLEBryant Ranch Prepackee33be35-abc8-453f-98e9-7974026b7eb02024-08-22Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Aripiprazole
generic name: ARIPIPRAZOLE
AripiprazoleARIPIPRAZOLEA-S Medication Solutionsc8a94428-b6d2-428b-a3a5-7b983d572fab2024-06-05Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Aripiprazole
generic name: ARIPIPRAZOLE
aripiprazoleARIPIPRAZOLEA-S Medication Solutionsab3973f3-3db8-4db2-8258-1b21af7b63802024-06-05Boxed warning, Warnings, Adverse reactionsName fallback
brand name: aripiprazole
generic name: ARIPIPRAZOLE
AripiprazoleARIPIPRAZOLEA-S Medication Solutions13339e7f-a8b4-430d-b623-47372de983482024-06-05Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Aripiprazole
generic name: ARIPIPRAZOLE
AripiprazoleARIPIPRAZOLEA-S Medication Solutions3ab6af7c-3169-46bf-bd3f-697c81bbcede2024-06-05Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Aripiprazole
generic name: ARIPIPRAZOLE
ARIPIPRAZOLEARIPIPRAZOLESolco Healthcare U.S., LLCabb8ad7e-7998-4485-a09f-a2892190f4ad2024-04-23Boxed warning, Warnings, Adverse reactionsName fallback
brand name: ARIPIPRAZOLE
generic name: ARIPIPRAZOLE
AripiprazoleARIPIPRAZOLEA-S Medication Solutions89c2cddc-2ae3-4505-adf9-018542c713bf2024-04-11Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Aripiprazole
generic name: ARIPIPRAZOLE
AripiprazoleARIPIPRAZOLEBryant Ranch Prepack3c0109f6-0549-4f91-a259-d9d6d7329b912024-04-05Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Aripiprazole
generic name: ARIPIPRAZOLE
AripiprazoleARIPIPRAZOLEBryant Ranch Prepack6b0c3767-d397-4c7f-b229-083620d9ae6b2024-04-05Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Aripiprazole
generic name: ARIPIPRAZOLE
AripiprazoleARIPIPRAZOLE ORALNorthStar RxLLC4a0a2f6c-d7bb-48d1-b5ca-066f27f78e412024-04-04Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Aripiprazole

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
81193ORIG 2025-02-10