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 41 of 83 · 1,660 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Genuine First Aid Hand SanitizerALCOHOLGFA Production(Xiamen) Co.,Ltd0aaee809-d251-6119-e063-6294a90aee7a2025-11-07WarningsName fallback
generic name: ALCOHOL
PURELL Hand Sanitizing Wipes Alcohol FormulaALCOHOLGOJO Industries, Inc.390859de-2d8d-40f8-a0fc-05f7644e266c2025-11-06WarningsName fallback
generic name: ALCOHOL
PURELL Healthcare Advanced Hand Sanitizer FoamALCOHOLGOJO Industries, Inc.d7f06d27-bc15-434f-8572-cd916d9924b22025-11-04WarningsName fallback
generic name: ALCOHOL
PSSI E-SanALCOHOLSafe Foods Chemical Innovationsb688fc4b-620a-2caf-e053-2995a90a30772025-11-04WarningsName fallback
generic name: ALCOHOL
PSSI E-SanALCOHOLSafe Foods Chemical Innovationsa2552024-afe9-4849-e053-2995a90a38172025-11-04WarningsName fallback
generic name: ALCOHOL
MyHealth Alcohol Antiseptic Hand SanitizerALCOHOLAeroflex Industria de Aerosol Ltdaf8eeb819-ec48-41a4-920c-7cdae55d7ecd2025-10-31WarningsName fallback
generic name: ALCOHOL
MyHealth Advanced Hand SanitizerALCOHOLAeroflex Industria de Aerosol Ltda0e3b2c36-57d7-438b-a2fc-fa9f00d9a5522025-10-31WarningsName fallback
generic name: ALCOHOL
Surface x Cutie Pals Hand Sanitizer Citrus CrushALCOHOLLongway Technology(Guangzhou)Co., Ltd.675ab652-d867-4613-8d3a-f0631da9b8622025-10-30WarningsName fallback
generic name: ALCOHOL
Surface x Cutie Pals Hand Sanitizer Coconut MilkALCOHOLLongway Technology(Guangzhou)Co., Ltd.e0a473b6-0d56-4566-b533-17dfb9c51ab62025-10-30WarningsName fallback
generic name: ALCOHOL
Surface x Cutie Pals Hand Sanitizer SurpriseALCOHOLLongway Technology(Guangzhou)Co., Ltd.ead7cefb-49b5-4405-a2bc-333f11280a0e2025-10-30WarningsName fallback
generic name: ALCOHOL
Symmetry Hand SanitizerALCOHOLBuckeye International, Inc.7f38c146-b5d3-489e-b1c7-89dcea2c18a82025-10-29Warnings, Adverse reactionsName fallback
generic name: ALCOHOL
Hand SanitizerALCOHOLCharlotte Products Ltd.1fbfe3f9-e0db-a3a2-e063-6294a90ab6aa2025-10-28WarningsName fallback
generic name: ALCOHOL
HAND SANITIZING LAVENDERALCOHOLDR. BRONNER'S MAGIC SOAPS8383605a-0bac-428c-b1cb-2f95ce9bd35e2025-10-28WarningsName fallback
generic name: ALCOHOL
ORGANIC HAND SANITIZER PEPPERMINTALCOHOLDR. BRONNER'S MAGIC SOAPScad3a81e-88cb-4f44-a351-b086fd9837952025-10-28WarningsName fallback
generic name: ALCOHOL
SanicleanALCOHOLSimoniz Saniclean, LLC422533a2-9e14-8c7a-e063-6394a90a27e72025-10-27WarningsName fallback
generic name: ALCOHOL
Germ Attack Hand SanitizerALCOHOLNatural Essentials, Inc.637dcb5f-8870-4613-a227-9fd6126170612025-10-27WarningsName fallback
generic name: ALCOHOL
Hand SanitizerALCOHOLCardinal Healthcc0a6e1e-ec95-cb48-e053-2a95a90ac0ce2025-10-23WarningsName fallback
generic name: ALCOHOL
WIDESPREAD Hand Sanitizing WipesALCOHOLHAMAOUI TRADING CORP.417df1ac-fa23-4d99-e063-6294a90a7d0f2025-10-20WarningsName fallback
generic name: ALCOHOL
Smart Care Luxury Hand Sanitizer Tangy TerraneALCOHOLShenzhen Lantern Scicence Co.,Ltd.4192dbc6-5d9a-d42a-e063-6394a90aa2d82025-10-20WarningsName fallback
generic name: ALCOHOL
Smart Care Luxury Hand Sanitizer Sweet and StillALCOHOLShenzhen Lantern Scicence Co.,Ltd.41934870-d87e-1c51-e063-6294a90abd2d2025-10-20WarningsName fallback
generic name: ALCOHOL

Reported adverse events (FAERS/openFDA)#

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