FDA.reportPublic FDA data

Application 083483

Type
ANDA
Sponsor
MILES

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ALCOHOL 5% IN DEXTROSE 5%ALCOHOLINJECTABLE;INJECTION5ML/100MLNoNo

Source provenance: Browse the complete Orange Book source catalog.

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
2019-12-13 00:20 UTC2019-12A083483-001ALCOHOL 5% IN DEXTROSE 5%5ML/100MLINJECTABLE / INJECTIONApproved before 198274a2ff9319b5…
2021-12-28 21:50 UTC2021-12A083483-001ALCOHOL 5% IN DEXTROSE 5%5ML/100MLINJECTABLE / INJECTIONApproved before 1982782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A083483-001ALCOHOL 5% IN DEXTROSE 5%5ML/100MLINJECTABLE / INJECTIONApproved before 198287673890dc5c…
2021-03-12 10:30 UTC2021-03A083483-001ALCOHOL 5% IN DEXTROSE 5%5ML/100MLINJECTABLE / INJECTIONApproved before 19825aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A083483-001ALCOHOL 5% IN DEXTROSE 5%5ML/100MLINJECTABLE / INJECTIONApproved before 19828869cabd3fbd…
2020-11-12 02:37 UTC2020-11A083483-001ALCOHOL 5% IN DEXTROSE 5%5ML/100MLINJECTABLE / INJECTIONApproved before 1982c0c555d07b60…
2019-12-14 00:12 UTC2019-12A083483-001ALCOHOL 5% IN DEXTROSE 5%5ML/100MLINJECTABLE / INJECTIONApproved before 19823f01610625f2…
2019-09-15 20:21 UTC2019-09A083483-001ALCOHOL 5% IN DEXTROSE 5%5ML/100MLINJECTABLE / INJECTIONApproved before 1982b00525d2431f…
2019-07-19 19:46 UTC2019-07A083483-001ALCOHOL 5% IN DEXTROSE 5%5ML/100MLINJECTABLE / INJECTIONApproved before 1982ea99ee380514…

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 80 of 82 · 1,638 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cucumber and Melon Scented Hand SanitizerALCOHOLFOURSTAR GROUP USA, INC.c090c632-ecae-3c13-e053-2995a90a130d2023-10-26WarningsName fallback
generic name: ALCOHOL
Aloe scented anti-bacterial hand sanitizerALCOHOLFOURSTAR GROUP USA, INC.c55d0287-ff05-82dd-e053-2995a90af78f2023-10-26WarningsName fallback
generic name: ALCOHOL
Rose scented anti-bacterial hand sanitizerALCOHOLFOURSTAR GROUP USA, INC.c55d3036-1d0d-0cbf-e053-2995a90a1e042023-10-26WarningsName fallback
generic name: ALCOHOL
Pomegranate and Vanilla Scented Hand SanitizerALCOHOLFOURSTAR GROUP USA, INC.c09137da-36ac-7fcf-e053-2a95a90a63962023-10-26WarningsName fallback
generic name: ALCOHOL
Jasmine scented anti-bacterial hand sanitizerALCOHOLFOURSTAR GROUP USA, INC.c55e09b0-c61f-3037-e053-2995a90a72e22023-10-26WarningsName fallback
generic name: ALCOHOL
CHERRY BLOSSOM SCENTED HAND SANITIZERALCOHOLFourstar Group USA, Inc.06e7d79d-6c12-45db-8da4-96f8505966bd2023-10-26WarningsName fallback
generic name: ALCOHOL
BERRY SCENTED CLIP ON HAND SANITIZERALCOHOLFourstar Group USA, Inc.87887e2c-dde0-4753-8f7a-2747a1ff2a9d2023-10-26WarningsName fallback
generic name: ALCOHOL
CHAI LATTE SCENTED HAND SANITIZERALCOHOLFourstar Group USA, Inc.4925eaed-f427-44dd-a456-d00aaec6a0322023-10-26WarningsName fallback
generic name: ALCOHOL
CHAI LATTE SCENTED CLIP ON HAND SANITIZERALCOHOLFourstar Group USA, Inc.144d694a-b807-44fe-af13-91b8de1605812023-10-26WarningsName fallback
generic name: ALCOHOL
PUMPKIN SPICE SCENTED HAND SANITIZERALCOHOLFourstar Group USA, Inc.f4de93d9-ac50-45af-aacd-62c7b325ce1c2023-10-26WarningsName fallback
generic name: ALCOHOL
Aloe Scented Hand SanitizerALCOHOLFourstar Group USA, Inc.d641ac0d-c25b-4727-b7da-107cdc3312af2023-10-26WarningsName fallback
generic name: ALCOHOL
PUMPKIN SPICE SCENTED CLIP ON HAND SANITIZERALCOHOLFourstar Group USA, Inc.7b099ca8-3045-416d-86f0-36885a280b622023-10-26WarningsName fallback
generic name: ALCOHOL
Lavender Scented Hand SanitizerALCOHOLFourstar Group USA, Inc.f87f4df2-a595-45e7-b1d0-8f0247c270932023-10-26WarningsName fallback
generic name: ALCOHOL
Jasmine Scented Hand SanitizerALCOHOLFourstar Group USA, Inc.a1d07799-1b5d-464f-bfe3-3779706375d82023-10-26WarningsName fallback
generic name: ALCOHOL
Rose Scented Hand SanitizerALCOHOLFourstar Group USA, Inc.b986a0e8-aadf-44dd-a1a8-dcea7c1e66b52023-10-26WarningsName fallback
generic name: ALCOHOL
Zeyco Antiseptic Hand Sanitizer GelALCOHOLLaboratorios Zeyco, S.A. de C.V.a85df538-dedd-7617-e053-2995a90a4a362023-10-26WarningsName fallback
generic name: ALCOHOL
Antiseptic Hand SanitizerALCOHOLLaboratorios Zeyco, S.A. de C.V.ad14b387-e280-8dab-e053-2995a90a590c2023-10-26WarningsName fallback
generic name: ALCOHOL
Antibacterial Hand SanitizerALCOHOLLaboratorios Zeyco, S.A. de C.V.a58cf759-0485-6740-e053-2a95a90a8b432023-10-26WarningsName fallback
generic name: ALCOHOL
Zeyco Hand SanitizerALCOHOLLaboratorios Zeyco, S.A. de C.V.aa073f96-5774-c12f-e053-2a95a90aec222023-10-26WarningsName fallback
generic name: ALCOHOL
Monarch Hand SanitizerALCOHOLLaboratorios Zeyco, S.A. de C.V.aa920f62-352c-4c67-9575-e78f12edef842023-10-26WarningsName fallback
generic name: ALCOHOL

Reported adverse events (FAERS/openFDA)#

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