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 67 of 82 · 1,638 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Anti Bacterial Hand Gel Champagne ToastALCOHOLBath & Body Works, Inc.1ba6a544-2748-68ff-e063-6394a90a63c32024-06-24WarningsName fallback
generic name: ALCOHOL
STAYKLEARALCOHOLeHealth Nexus LLCc8b31580-5672-61de-e053-2995a90a3e782024-06-24WarningsName fallback
generic name: ALCOHOL
b pure Hydrating Hand Sanitizer Vanilla Sugar Cookie ScentedALCOHOLFOURSTAR GROUP USA, INC.162a9382-134f-42c1-8961-bcb281be282c2024-06-24WarningsName fallback
generic name: ALCOHOL
b pure Hydrating Hand Sanitizer Frosted Coconut ScentedALCOHOLFOURSTAR GROUP USA, INC.dd57d7fa-deb3-4b02-a9cc-a39153afa0492024-06-24WarningsName fallback
generic name: ALCOHOL
Anti Bacterial Hand Gel Love Always WinsALCOHOLBath & Body Works, Inc.1b6a8105-53d2-8e0f-e063-6394a90a64af2024-06-21WarningsName fallback
generic name: ALCOHOL
Anti Bacterial Hand Gel Kitchen MandarinALCOHOLBath & Body Works, Inc.1b2e5934-5914-2060-e063-6394a90ae0d32024-06-18WarningsName fallback
generic name: ALCOHOL
Anti Bacterial Hand Gel Island MargaritaALCOHOLBath & Body Works, Inc.1ac7101d-bef1-7db6-e063-6294a90aca922024-06-13WarningsName fallback
generic name: ALCOHOL
Anti Bacterial Hand Gel Gingham UnstoppableALCOHOLBath & Body Works, Inc.1ab80018-e9c2-a8eb-e063-6394a90a97f72024-06-12WarningsName fallback
generic name: ALCOHOL
Anti Bacterial Hand Gel Gingham GlowALCOHOLBath & Body Works, Inc.1aa32eca-8cf6-75cb-e063-6294a90ab72b2024-06-12WarningsName fallback
generic name: ALCOHOL
Anti Bacterial Hand Gel Iced Lemon Pound CakeALCOHOLBath & Body Works, Inc.1ab87e4e-828e-75dd-e063-6294a90a81212024-06-12WarningsName fallback
generic name: ALCOHOL
Anti Bacterial Hand Gel First SightALCOHOLBath & Body Works, Inc.1a9e9349-9495-81a5-e063-6294a90a7b7b2024-06-11WarningsName fallback
generic name: ALCOHOL
Anti Bacterial Hand Gel Flower ChildALCOHOLBath & Body Works, Inc.1a9ef8eb-325f-8c42-e063-6394a90a1ecc2024-06-11WarningsName fallback
generic name: ALCOHOL
Anti Bacterial Hand Gel Fresh Amalfi LemonALCOHOLBath & Body Works, Inc.1a9f2550-319d-ea51-e063-6394a90ab0aa2024-06-11WarningsName fallback
generic name: ALCOHOL
Anti Bacterial Hand Gel Fresh Cut LilacsALCOHOLBath & Body Works, Inc.1a9f4c77-1afb-35f2-e063-6394a90a82b92024-06-11WarningsName fallback
generic name: ALCOHOL
Anti Bacterial Hand Gel Ghoul FriendALCOHOLBath & Body Works, Inc.1a9f6a23-1429-573d-e063-6394a90a0ea42024-06-11WarningsName fallback
generic name: ALCOHOL
Anti Bacterial Hand Gel GinghamALCOHOLBath & Body Works, Inc.1aa2967a-d978-d294-e063-6294a90a25122024-06-11WarningsName fallback
generic name: ALCOHOL
Anti Bacterial Hand Gel Danbury ShortbreadALCOHOLBath & Body Works, Inc.1a8e81c0-c97d-100c-e063-6394a90ab2072024-06-10WarningsName fallback
generic name: ALCOHOL
Anti Bacterial Hand Gel Diamond Of The SeasonALCOHOLBath & Body Works, Inc.1a8e710e-521f-2d66-e063-6394a90a80de2024-06-10WarningsName fallback
generic name: ALCOHOL
Anti Bacterial Hand Gel Dressed In WhiteALCOHOLBath & Body Works, Inc.1a8eaa81-c110-69f1-e063-6394a90ab2642024-06-10WarningsName fallback
generic name: ALCOHOL
Anti Bacterial Hand Gel Endless WeekendALCOHOLBath & Body Works, Inc.1a8ebd8c-f7c6-9bf8-e063-6394a90ad8a82024-06-10WarningsName fallback
generic name: ALCOHOL

Reported adverse events (FAERS/openFDA)#

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