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 20 of 83 · 1,660 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
B Pure Moisturizing Hand Sanitizer Palm Island Breeze ScentedALCOHOLFourstar Group USA, Inc.afe2d7d6-7ce8-4115-b175-6ab39402eb792026-03-25WarningsName fallback
generic name: ALCOHOL
Los Poblanos Lavender Hand SanitizerALCOHOLSombra Cosmetics Inc.4ddef71b-f5b8-57f5-e063-6294a90a78a32026-03-25WarningsName fallback
generic name: ALCOHOL
Avant 70% Alcohol GelALCOHOLB4 Soap LLC241f4334-2e88-4f7b-a0c7-c93da9f5086c2026-03-18WarningsName fallback
generic name: ALCOHOL
Sterillium comfortALCOHOLBODE Chemie GmbH2d48dab8-f70a-a2b5-e063-6294a90a14562026-03-16WarningsName fallback
generic name: ALCOHOL
Limited Edition Hand Sanitizer Pink Satin ProseccoALCOHOLScent Theory Products LLC4d278204-9331-aeb8-e063-6394a90a87a42026-03-16WarningsName fallback
generic name: ALCOHOL
Limited Edition Hand Sanitizer Cherry ChaiALCOHOLScent Theory Products LLC4d27a964-6e91-27c0-e063-6294a90ad9942026-03-16WarningsName fallback
generic name: ALCOHOL
Sterillium FoamALCOHOLBODE Chemie GmbH93680cd8-609f-48f2-e053-2995a90aa3552026-03-16WarningsName fallback
generic name: ALCOHOL
Sterillium rub fragrance-freeALCOHOLBODE Chemie GmbH2bc46854-fe65-782b-e063-6294a90a79af2026-03-16WarningsName fallback
generic name: ALCOHOL
Hand SanitizerALCOHOLNice-Pak Products, LLC9bed5445-3e25-43e8-840a-9e3443b5a8512026-03-13Warnings, Adverse reactionsName fallback
generic name: ALCOHOL
Hand SanitizerALCOHOLProStat First Aid4cd4c51c-88bb-3797-e063-6294a90a8f702026-03-12WarningsName fallback
generic name: ALCOHOL
Limited Edition Hand Sanitizer Cashmere SkinALCOHOLScent Theory Products LLC4cdc4282-eb49-3120-e063-6294a90a2d612026-03-12WarningsName fallback
generic name: ALCOHOL
Hand SanitizerALCOHOLUpLift Brands, LLCba4be8c2-00ce-48e6-a83c-6c1bde3c3aa42026-03-11Warnings, Adverse reactionsName fallback
generic name: ALCOHOL
Anti Bacterial Hand Gel Whipped Vanilla CloudsALCOHOLBath & Body Works, Inc.46178c56-3e33-4523-e063-6394a90aca792026-03-10WarningsName fallback
generic name: ALCOHOL
Anti Bacterial Hand Gel Blue Raspberry FreezeALCOHOLBath & Body Works, Inc.4616db35-113d-970f-e063-6394a90aa38d2026-03-10WarningsName fallback
generic name: ALCOHOL
Anti Bacterial Hand Gel Pistachio Milk and HoneyALCOHOLBath & Body Works, Inc.4616f2ce-1b5e-436d-e063-6394a90acbe22026-03-10WarningsName fallback
generic name: ALCOHOL
Anti Bacterial Hand Gel Sparkling WatermelonALCOHOLBath & Body Works, Inc.46156243-39d7-f56c-e063-6394a90a2d2c2026-03-10WarningsName fallback
generic name: ALCOHOL
Anti Bacterial Hand Gel Raspberries and Whipped VanillaALCOHOLBath & Body Works, Inc.46179a73-7a7b-7e3b-e063-6294a90a06d62026-03-10WarningsName fallback
generic name: ALCOHOL
Anti Bacterial Hand Gel Mini Cookie BitesALCOHOLBath & Body Works, Inc.46171e50-519f-c877-e063-6294a90acc762026-03-10WarningsName fallback
generic name: ALCOHOL
Anti Bacterial Hand Gel Gummi SnacksALCOHOLBath & Body Works, Inc.46174492-efb9-cf84-e063-6294a90a0c462026-03-10WarningsName fallback
generic name: ALCOHOL
Anti Bacterial Hand Gel White PumpkinALCOHOLBath & Body Works, Inc.4617c406-26da-867b-e063-6394a90ae2a22026-03-10WarningsName fallback
generic name: ALCOHOL

Reported adverse events (FAERS/openFDA)#

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