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 2 of 7 · 121 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AripiprazoleARIPIPRAZOLECoupler LLC52bbfc8f-fa17-839e-e063-6394a90a63162026-05-26Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Aripiprazole
generic name: ARIPIPRAZOLE
AripiprazoleARIPIPRAZOLEMajor Pharmaceuticals573c6bb6-941f-4413-8c23-8260253858642026-05-21Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Aripiprazole
generic name: ARIPIPRAZOLE
aripiprazoleARIPIPRAZOLEREMEDYREPACK INC.9b695d4b-3794-4b89-8575-6feb83697ccc2026-05-18Boxed warning, Warnings, Adverse reactionsName fallback
brand name: aripiprazole
generic name: ARIPIPRAZOLE
AripiprazoleARIPIPRAZOLEBryant Ranch Prepackc092a736-16e2-4dd0-8769-cb766a62f4d92026-05-13Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Aripiprazole
generic name: ARIPIPRAZOLE
AripiprazoleARIPIPRAZOLECoupler LLC512874e6-6d00-2623-e063-6394a90aa4bc2026-05-06Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Aripiprazole
generic name: ARIPIPRAZOLE
AripiprazoleARIPIPRAZOLECoupler LLC50214c47-2ea3-b373-e063-6394a90aad232026-04-23Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Aripiprazole
generic name: ARIPIPRAZOLE
AripiprazoleARIPIPRAZOLEREMEDYREPACK INC.6f580e75-61ab-4c7b-bb3f-f027a9603f842026-04-03Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Aripiprazole
generic name: ARIPIPRAZOLE
ABILIFY MAINTENAARIPIPRAZOLEOtsuka America Pharmaceutical, Inc.ee49f3b1-1650-47ff-9fb1-ea53fe0b92b62026-03-24Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ARIPIPRAZOLE
AripiprazoleARIPIPRAZOLEREMEDYREPACK INC.433cdc7d-465a-4ad4-bd84-cabd37e15f512026-03-19Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Aripiprazole
generic name: ARIPIPRAZOLE
aripiprazoleARIPIPRAZOLEMajor Pharmaceuticals969c17aa-6abc-413c-8561-f1ad8fdde3e52026-03-17Boxed warning, Warnings, Adverse reactionsName fallback
brand name: aripiprazole
generic name: ARIPIPRAZOLE
AripiprazoleARIPIPRAZOLEPreferred Pharmaceuticals, Inc.36fb0c13-dfae-46ac-bb71-0b53fe5649f42026-03-05Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Aripiprazole
generic name: ARIPIPRAZOLE
AripiprazoleARIPIPRAZOLEPreferred Pharmaceuticals Inc.02a4af27-c83c-4166-950c-7a1cb12d198d2026-03-05Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Aripiprazole
generic name: ARIPIPRAZOLE
AripiprazoleARIPIPRAZOLEBryant Ranch Prepackff8dc838-ca1a-49d3-8938-5ae645574a752026-03-05Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Aripiprazole
generic name: ARIPIPRAZOLE
AripiprazoleARIPIPRAZOLEREMEDYREPACK INC.2bc00231-c2e7-4b9d-93a1-fb796fd8d5912026-02-11Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Aripiprazole
generic name: ARIPIPRAZOLE
AripiprazoleARIPIPRAZOLEBryant Ranch Prepack1e8d889e-126b-4627-a2cc-34f2d35a5d672026-01-28Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Aripiprazole
generic name: ARIPIPRAZOLE
AripiprazoleARIPIPRAZOLEBryant Ranch Prepack1ef9e44f-5672-47c2-97e9-286e1b84417d2026-01-28Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Aripiprazole
generic name: ARIPIPRAZOLE
AripiprazoleARIPIPRAZOLEBryant Ranch Prepack4bda6f17-d87c-4009-b329-99275c56106f2026-01-27Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Aripiprazole
generic name: ARIPIPRAZOLE
AripiprazoleARIPIPRAZOLEBryant Ranch Prepackfb40b669-4e37-4087-8fb1-3ac1405436022026-01-27Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Aripiprazole
generic name: ARIPIPRAZOLE
AripiprazoleARIPIPRAZOLEA-S Medication Solutions554db933-aa80-4685-bcd5-58c84571c19c2026-01-06Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Aripiprazole
generic name: ARIPIPRAZOLE
AripiprazoleARIPIPRAZOLECoupler LLC47430dfa-9377-6c31-e063-6394a90a86a92025-12-31Boxed 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