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 6 of 7 · 121 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AripiprazoleARIPIPRAZOLEBryant Ranch Prepack96172aa4-9e13-4eca-83d5-85a88c1782d32024-04-03Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Aripiprazole
generic name: ARIPIPRAZOLE
ARIPIPRAZOLEARIPIPRAZOLEA-S Medication Solutionsdb6fc74e-4989-464d-9c19-a5b7a541fd462024-03-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: ARIPIPRAZOLE
generic name: ARIPIPRAZOLE
AripiprazoleARIPIPRAZOLECamber Pharmaceuticals, Inc.2d8d574b-fbf4-4d2c-a37c-25556ecbf1aa2024-02-02Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Aripiprazole
generic name: ARIPIPRAZOLE
AripiprazoleARIPIPRAZOLEBryant Ranch Prepackfd2fa4da-2ee9-4965-b1f8-ce1c8b73ba932023-11-22Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Aripiprazole
generic name: ARIPIPRAZOLE
AripiprazoleARIPIPRAZOLEProficient Rx LPfbd81df7-8482-493e-bfc5-a3352f466b9e2023-10-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Aripiprazole
generic name: ARIPIPRAZOLE
AripiprazoleARIPIPRAZOLENorthStar RxLLCf87dbfe4-5417-47c9-a97f-d246cfc100232023-08-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Aripiprazole
generic name: ARIPIPRAZOLE
AripiprazoleARIPIPRAZOLESQUARE PHARMACEUTICALS LIMITED0f9b1fd8-a648-45c9-8655-14de07439f342023-07-02Name fallback
brand name: Aripiprazole
generic name: ARIPIPRAZOLE
AripiprazoleARIPIPRAZOLEXLCare Pharmaceuticals, Inc.0a6fa113-6bb2-4f88-af07-ce0914c98ff22023-06-16Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Aripiprazole
generic name: ARIPIPRAZOLE
AripiprazoleARIPIPRAZOLEScieGen Pharmaceuticals Inca7d9d5d1-25ba-4f4e-a990-398c0bf09c7e2023-02-20Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Aripiprazole
generic name: ARIPIPRAZOLE
AripiprazoleARIPIPRAZOLEAlembic Pharmaceuticals Limited4f1691a8-724e-430d-9bab-27b59ef9bd4e2023-01-27Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Aripiprazole
generic name: ARIPIPRAZOLE
AripiprazoleARIPIPRAZOLEAlembic Pharmaceuticals Limited793fc904-2f11-4f97-a0ac-4d6910cac0f92023-01-27Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Aripiprazole
generic name: ARIPIPRAZOLE
AripiprazoleARIPIPRAZOLEXLCare Pharmaceuticals, Inc.b284b294-40a0-4ccd-b7b7-b61267cd4e762023-01-16Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Aripiprazole
generic name: ARIPIPRAZOLE
ARIPIPRAZOLEARIPIPRAZOLEA-S Medication Solutionsaaf7dc7e-04f3-442b-86d7-5f54d17d102c2022-09-12Boxed warning, Warnings, Adverse reactionsName fallback
brand name: ARIPIPRAZOLE
generic name: ARIPIPRAZOLE
AripiprazoleARIPIPRAZOLENCS HealthCare of KY, LLC dba Vangard Labs8da99c93-613e-4b78-9f91-3efc2dea194d2022-08-02Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Aripiprazole
generic name: ARIPIPRAZOLE
AripiprazoleARIPIPRAZOLEProficient Rx LP19a3c2f2-11eb-4ec9-ac38-134168bdf99c2022-08-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Aripiprazole
generic name: ARIPIPRAZOLE
AripiprazoleARIPIPRAZOLEProficient Rx LP11202c0a-7401-41c9-b1e7-d93739fcd36f2022-06-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Aripiprazole
generic name: ARIPIPRAZOLE
AripiprazoleARIPIPRAZOLEDr.Reddys Laboratories Inc0aa7e178-456a-4942-93aa-9ec18a58939f2020-06-16Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Aripiprazole
generic name: ARIPIPRAZOLE
AripiprazoleARIPIPRAZOLEScieGen Pharmaceuticals Inc95954ba3-e838-4dd7-aef1-c51ac6aff76b2020-05-06Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Aripiprazole
generic name: ARIPIPRAZOLE
AripiprazoleARIPIPRAZOLEProficient Rx LPdbdc8fbe-c75f-4f17-a2cd-9f23802dcc5d2019-11-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Aripiprazole
generic name: ARIPIPRAZOLE
AripiprazoleARIPIPRAZOLEExelan Pharmaceuticals, Inc.705190bf-9f9d-4183-a56b-4eeafeacde592018-12-28Boxed 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.

Documents#

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