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 1.

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
2026-02-19 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 1 of 6 · 118 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AripiprazoleARIPIPRAZOLEREMEDYREPACK INC.bc3fde41-2f24-44e2-815d-15fe55bd68b32026-07-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Aripiprazole
generic name: ARIPIPRAZOLE
AripiprazoleARIPIPRAZOLEREMEDYREPACK INC.506fa28f-6f98-4632-bce8-72a9cb507c902026-07-29Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Aripiprazole
generic name: ARIPIPRAZOLE
AripiprazoleARIPIPRAZOLEREMEDYREPACK INC.f713c38e-cc49-4243-96b9-32d5dbbcf9cb2026-07-29Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Aripiprazole
generic name: ARIPIPRAZOLE
aripiprazoleARIPIPRAZOLEREMEDYREPACK INC.1ad7d167-1235-4c5c-8159-da8972240ede2026-07-27Boxed warning, Warnings, Adverse reactionsName fallback
brand name: aripiprazole
generic name: ARIPIPRAZOLE
AripiprazoleARIPIPRAZOLEREMEDYREPACK INC.119e3387-39a2-4fe5-904b-c2d008425c0a2026-07-22Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Aripiprazole
generic name: ARIPIPRAZOLE
AripiprazoleARIPIPRAZOLE ORALLY DISINTEGRATINGDr. Reddy's Laboratories Inc394ea4a4-3991-4f98-b38f-56e9335d66b32026-07-21Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Aripiprazole
AripiprazoleARIPIPRAZOLEREMEDYREPACK INC.99747897-22fe-4bee-9942-6349c0c8f6b02026-07-17Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Aripiprazole
generic name: ARIPIPRAZOLE
AripiprazoleARIPIPRAZOLE ORALATLANTIC BIOLOGICALS CORP.042b725c-1c17-4cfb-80b2-c841226d795e2026-07-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Aripiprazole
AripiprazoleARIPIPRAZOLECoupler LLC56439ef6-a07e-34c9-e063-6294a90a77c32026-07-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Aripiprazole
generic name: ARIPIPRAZOLE
AripiprazoleARIPIPRAZOLECoupler LLC55f3a705-9412-0f88-e063-6294a90a2b532026-07-06Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Aripiprazole
generic name: ARIPIPRAZOLE
AripiprazoleARIPIPRAZOLECoupler LLC55f446b0-caa2-aca8-e063-6294a90af4412026-07-06Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Aripiprazole
generic name: ARIPIPRAZOLE
AripiprazoleARIPIPRAZOLEREMEDYREPACK INC.a1191a90-eb83-4a59-948c-b9774d2c83a52026-07-02Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Aripiprazole
generic name: ARIPIPRAZOLE
AripiprazoleARIPIPRAZOLEBryant Ranch Prepack69af5199-f872-4298-8d09-035e2127d3d42026-06-29Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Aripiprazole
generic name: ARIPIPRAZOLE
AripiprazoleARIPIPRAZOLEUnit Dose Solutions, Inc.535f4fbd-b6a7-7611-e063-6294a90a5c432026-06-03Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Aripiprazole
generic name: ARIPIPRAZOLE
AripiprazoleARIPIPRAZOLECoupler LLC52cc86ba-2c4f-1aba-e063-6294a90a844e2026-05-27Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Aripiprazole
generic name: ARIPIPRAZOLE
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

Documents#

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