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 28 of 83 · 1,660 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Anti Bacterial Hand Gel Lavender and VanillaALCOHOLBath & Body Works, Inc.38e1c1d6-6511-4066-e063-6294a90ad3f42026-03-02WarningsName fallback
generic name: ALCOHOL
Anti-BacterialHandSpray White T ShirtALCOHOLBath & Body Works, Inc.29a38d22-0685-37af-e063-6294a90a31e62026-03-02WarningsName fallback
generic name: ALCOHOL
Anti-BacterialHandSpray Passionfruit and Banana FlowerALCOHOLBath & Body Works, Inc.38d5d6c2-8ceb-40b7-e063-6394a90a2a8f2026-03-02WarningsName fallback
generic name: ALCOHOL
Anti-BacterialHandSpray A Thousand WishesALCOHOLBath & Body Works, Inc.29a3aac8-2083-3ece-e063-6394a90ab4402026-03-02WarningsName fallback
generic name: ALCOHOL
Anti-BacterialHandSpray OceanALCOHOLBath & Body Works, Inc.29a38d22-068a-37af-e063-6294a90a31e62026-03-02WarningsName fallback
generic name: ALCOHOL
Anti-BacterialHandSpray Champagne ToastALCOHOLBath & Body Works, Inc.29a3aa8a-c697-a873-e063-6294a90a72c42026-03-02WarningsName fallback
generic name: ALCOHOL
Anti-BacterialHandSpray Peach BelliniALCOHOLBath & Body Works, Inc.297e26d2-128e-0aa5-e063-6294a90a34dc2026-03-02WarningsName fallback
generic name: ALCOHOL
Anti-BacterialHandSpray Waikiki Beach CoconutALCOHOLBath & Body Works, Inc.38d5cfd5-db0d-4735-e063-6394a90a42a82026-03-02WarningsName fallback
generic name: ALCOHOL
Anti-BacterialHandSpray Sunshine and LemonsALCOHOLBath & Body Works, Inc.297e95be-a862-9d13-e063-6294a90a9faa2026-03-02WarningsName fallback
generic name: ALCOHOL
Anti-BacterialHandSpray Sweet Kiwi and StarfruitALCOHOLBath & Body Works, Inc.38d5d1c4-7f5b-45af-e063-6394a90a9c472026-03-02WarningsName fallback
generic name: ALCOHOL
Anti-BacterialHandSpray OceanALCOHOLBath & Body Works, Inc.38d5c6ac-4e71-3e9e-e063-6394a90af6c22026-03-02WarningsName fallback
generic name: ALCOHOL
Anti-BacterialHandSpray Fresh RainfallALCOHOLBath & Body Works, Inc.29a359fa-66e9-a7d3-e063-6294a90a6d722026-03-02WarningsName fallback
generic name: ALCOHOL
Anti-BacterialHandSpray Strawberry Pound CakeALCOHOLBath & Body Works, Inc.38951e2b-0334-2970-e063-6394a90a6b442026-03-02WarningsName fallback
generic name: ALCOHOL
Anti-BacterialHandSpray Mahogany TeakwoodALCOHOLBath & Body Works, Inc.38d5c6ac-4e73-3e9e-e063-6394a90af6c22026-03-02WarningsName fallback
generic name: ALCOHOL
Anti-BacterialHandSpray Japanese Cherry BlossomALCOHOLBath & Body Works, Inc.38d5df93-a95e-9980-e063-6294a90a20a22026-03-02WarningsName fallback
generic name: ALCOHOL
Anti-BacterialHandSpray In The StarsALCOHOLBath & Body Works, Inc.29a3b5b3-c103-7754-e063-6294a90af8e72026-03-02WarningsName fallback
generic name: ALCOHOL
Anti Bacterial Moisturizing Hand Sanitizer Champagne ToastALCOHOLBath & Body Works, Inc.29294e13-e196-3ca2-e063-6294a90a92e02026-03-02WarningsName fallback
generic name: ALCOHOL
Anti Bacterial Moisturizing Hand Sanitizer Mahogany TeakwoodALCOHOLBath & Body Works, Inc.1bb85c27-d855-49c0-e063-6394a90a6a512026-03-02WarningsName fallback
generic name: ALCOHOL
Anti Bacterial Moisturizing Hand Sanitizer Sunshine and LemonsALCOHOLBath & Body Works, Inc.1bb99458-e528-d241-e063-6394a90a58b12026-03-02WarningsName fallback
generic name: ALCOHOL
Anti Bacterial Moisturizing Hand Sanitizer Fresh Cut LilacsALCOHOLBath & Body Works, Inc.387be420-3943-10ed-e063-6294a90ab79c2026-03-02WarningsName fallback
generic name: ALCOHOL

Reported adverse events (FAERS/openFDA)#

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