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 10 of 83 · 1,660 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Anti Bacterial Hand Gel Fiji White SandsALCOHOLBath & Body Works, Inc.552fbaea-cc8e-ff08-e063-6294a90aa0862026-06-26WarningsName fallback
generic name: ALCOHOL
Anti Bacterial Hand Gel Blue Washed SkyALCOHOLBath & Body Works, Inc.552fc18b-aa5e-e667-e063-6394a90a908e2026-06-26WarningsName fallback
generic name: ALCOHOL
Peepin It Real Disney Villains MaleficentALCOHOLBath & Body Works, Inc.552fc18b-aa62-e667-e063-6394a90a908e2026-06-26WarningsName fallback
generic name: ALCOHOL
Anti Bacterial Hand Gel Disney Princess MulanALCOHOLBath & Body Works, Inc.552fccdd-93bf-efff-e063-6294a90a54ba2026-06-26WarningsName fallback
generic name: ALCOHOL
Anti Bacterial Hand Gel Lifes A FairytaleALCOHOLBath & Body Works, Inc.552fc8da-e387-0dc5-e063-6294a90a9c0c2026-06-26WarningsName fallback
generic name: ALCOHOL
Anti Bacterial Hand Gel Sunshine and LemonsALCOHOLBath & Body Works, Inc.552fa700-4215-d614-e063-6394a90aa12f2026-06-26WarningsName fallback
generic name: ALCOHOL
Anti Bacterial Hand Gel Star Wars The Mandalorian and Grogu Force FlowALCOHOLBath & Body Works, Inc.552fbaea-cc8f-ff08-e063-6294a90aa0862026-06-26WarningsName fallback
generic name: ALCOHOL
Anti Bacterial Hand Gel Disney Princess TianaALCOHOLBath & Body Works, Inc.552fc414-20c6-dad6-e063-6394a90a44e82026-06-26WarningsName fallback
generic name: ALCOHOL
Anti Bacterial Hand Gel Disney Princess Snow WhiteALCOHOLBath & Body Works, Inc.552fbc11-171d-fe10-e063-6294a90ac2362026-06-26WarningsName fallback
generic name: ALCOHOL
Anti Bacterial Hand Gel Fresh Cut LilacsALCOHOLBath & Body Works, Inc.552fc40c-47f6-a2bc-e063-6394a90a1ba62026-06-26WarningsName fallback
generic name: ALCOHOL
Anti Bacterial Hand Gel Disney Princess RapunzelALCOHOLBath & Body Works, Inc.552fc8da-e386-0dc5-e063-6294a90a9c0c2026-06-26WarningsName fallback
generic name: ALCOHOL
Anti Bacterial Hand Gel Disney Princess AuroraALCOHOLBath & Body Works, Inc.552fc40c-47f8-a2bc-e063-6394a90a1ba62026-06-26WarningsName fallback
generic name: ALCOHOL
Anti Bacterial Moisturizing Hand Sanitizer Peach BelliniALCOHOLBath & Body Works, Inc.552fd963-5f09-0acc-e063-6294a90a2c142026-06-26WarningsName fallback
generic name: ALCOHOL
Anti Bacterial Moisturizing Hand Sanitizer Fresh RainfallALCOHOLBath & Body Works, Inc.552faf37-a7ff-df22-e063-6394a90a47cb2026-06-26WarningsName fallback
generic name: ALCOHOL
Anti Bacterial Moisturizing Hand Sanitizer Sparkling WatermelonALCOHOLBath & Body Works, Inc.552fe62e-5e14-1fed-e063-6294a90a489e2026-06-26WarningsName fallback
generic name: ALCOHOL
Anti Bacterial Moisturizing Hand Sanitizer Warm Vanilla SugarALCOHOLBath & Body Works, Inc.552fbc11-1720-fe10-e063-6294a90ac2362026-06-26WarningsName fallback
generic name: ALCOHOL
Anti Bacterial Moisturizing Hand Sanitizer Champagne ToastALCOHOLBath & Body Works, Inc.552fc4da-f24c-e88a-e063-6394a90ae2ab2026-06-26WarningsName fallback
generic name: ALCOHOL
Anti Bacterial Moisturizing Hand Sanitizer Eucalyptus MintALCOHOLBath & Body Works, Inc.552fc8da-e38a-0dc5-e063-6294a90a9c0c2026-06-26WarningsName fallback
generic name: ALCOHOL
Anti Bacterial Hand Gel Mango Papaya ParadiseALCOHOLBath & Body Works, Inc.552fe73b-38de-0c49-e063-6394a90a64742026-06-26WarningsName fallback
generic name: ALCOHOL
Anti Bacterial Moisturizing Hand Sanitizer Strawberry Peach SunsetALCOHOLBath & Body Works, Inc.552fe62e-5e13-1fed-e063-6294a90a489e2026-06-26WarningsName fallback
generic name: ALCOHOL

Reported adverse events (FAERS/openFDA)#

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