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 49 of 83 · 1,660 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Meijer Hydrating Power Mist Hand Sanitizer - GingerbreadALCOHOLShenzhen Lantern Scicence Co.,Ltd.34ecbd68-ddab-3e47-e063-6294a90a2e502025-05-12WarningsName fallback
generic name: ALCOHOL
Novo wipeALCOHOLJIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.4ea50d30-b75b-44dc-bda1-d3ac97b34af72025-05-12WarningsName fallback
generic name: ALCOHOL
B-Pure Hand Sanitizer Pumpkin ScentedALCOHOLFOURSTAR GROUP USA, INC.7ea6ec9d-323d-4f81-bc86-94cd0e6cc0142025-05-07WarningsName fallback
generic name: ALCOHOL
B-Pure Hand Sanitizer Sugar Cookie ScentedALCOHOLFOURSTAR GROUP USA, INC.29448472-af23-4ed2-93a9-9d57b7d8d0812025-05-07WarningsName fallback
generic name: ALCOHOL
B-Pure Hand Sanitizer Ginger Citrus ScentedALCOHOLFOURSTAR GROUP USA, INC.100184a8-6298-4c57-a831-cd5fa55a66b02025-05-07WarningsName fallback
generic name: ALCOHOL
B-Pure Moisturizing Hand Sanitizer Mocha Coffee ScentedALCOHOLFOURSTAR GROUP USA, INC.8130954d-ba43-478d-b260-b74eaa2ab3752025-05-05WarningsName fallback
generic name: ALCOHOL
B-Pure Moisturizing Hand Sanitizer Almond Vanilla ScentedALCOHOLFOURSTAR GROUP USA, INC.e9628d75-6271-47f7-8e96-cc06b2496b3b2025-05-05WarningsName fallback
generic name: ALCOHOL
Nozin Nasal Sanitizer (Antiseptic)ALCOHOLGlobal Life Technologies Corp.c670ac11-0656-4d85-868e-3a407c9952a32025-05-05WarningsName fallback
generic name: ALCOHOL
Moxe Hand Sanitizer Eucalyptus MintALCOHOLPremark Health Science21636fb2-0624-117e-e063-6394a90ab9eb2025-04-30WarningsName fallback
generic name: ALCOHOL
Moxe Citrus Splash Hand SanitizerALCOHOLPremark Health Science21f246d0-9133-efec-e063-6294a90aa2192025-04-30WarningsName fallback
generic name: ALCOHOL
Sterillium MedALCOHOLBODE Chemie GmbH8d80d5fd-7869-c551-e053-2995a90af2a92025-04-30WarningsName fallback
generic name: ALCOHOL
Sterillium ComfortALCOHOLBODE Chemie GmbH8efc9f4e-3b20-60ba-e053-2995a90af8b12025-04-30WarningsName fallback
generic name: ALCOHOL
Sanell Hand SanitizerALCOHOLOraLabs0a6cc2a8-f568-45ae-8d82-a70103c774c72025-04-28WarningsName fallback
generic name: ALCOHOL
Sanell Hand SanitizerALCOHOLOraLabs7184b9ad-0125-413d-b054-f46239b8ca922025-04-28WarningsName fallback
generic name: ALCOHOL
Pink Pineapple SCENTED HAND SANITIZERALCOHOLMELON BIO-TECH (THAILAND) CO., LTD.73543eed-e022-4d51-b606-000dcc0232982025-04-28WarningsName fallback
generic name: ALCOHOL
Vanilla Sugar SCENTED HAND SANITIZERALCOHOLMELON BIO-TECH (THAILAND) CO., LTD.6c790c49-7b4a-4e07-b5ce-9a31db84e01f2025-04-28WarningsName fallback
generic name: ALCOHOL
Strawberry Pound Cake SCENTED HAND SANITIZERALCOHOLMELON BIO-TECH (THAILAND) CO., LTD.34750790-4eec-4a2d-9686-2c69c1db79e62025-04-28WarningsName fallback
generic name: ALCOHOL
Sweet Coconut SCENTED HAND SANITIZERALCOHOLMELON BIO-TECH (THAILAND) CO., LTD.f9062bbc-8534-4dcc-920a-19f13d1c0def2025-04-28WarningsName fallback
generic name: ALCOHOL
PREVENT HAND SANITIZERALCOHOLAMERICAN CHEMICAL AND SANITARY SUPPLY INCee2c3dd2-a82f-4bbf-a288-f0365b9893db2025-04-23WarningsName fallback
generic name: ALCOHOL
SANIFOAM HAND SANITIZERALCOHOLAMERICAN CHEMICAL AND SANITARY SUPPLY INCe1cfa8ff-92e0-4931-98c9-287c8dcd5a992025-04-23WarningsName fallback
generic name: ALCOHOL

Reported adverse events (FAERS/openFDA)#

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