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 38 of 83 · 1,660 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
B-Pure Hand Sanitizer Palm Sugar Pineapple ScentedALCOHOLFourstar Group USA, Inc.34d065a1-c5f0-4ba0-8c1b-717049dcb83a2025-12-04WarningsName fallback
generic name: ALCOHOL
FoamFresh Alco-Foam Hand SanitizerALCOHOLWoodbine Products Company2e9c752c-ad69-4692-a17a-e98b84c7e9a52025-12-04WarningsName fallback
generic name: ALCOHOL
Mrs. Meyers Clean Day Hand Sanitizer Lavender ScentALCOHOLThe Caldrea Companyd60a985b-6b42-44ea-b48e-81556e4f609a2025-12-04WarningsName fallback
generic name: ALCOHOL
Smart Care Hand Sanitizer Jasmine GardeniaALCOHOLShenzhen Lantern Scicence Co.,Ltd.45082749-6f53-c595-e063-6294a90ac3e92025-12-03WarningsName fallback
generic name: ALCOHOL
Smart Care Hand Sanitizer StrawberryALCOHOLShenzhen Lantern Scicence Co.,Ltd.451752d3-88bc-9a26-e063-6294a90a288a2025-12-03WarningsName fallback
generic name: ALCOHOL
Smart Care Hand Sanitizer 3pk - Floral Fresh (Lavender/Wild rose/Rain)ALCOHOLShenzhen Lantern Scicence Co.,Ltd.45179a84-fa3c-5634-e063-6294a90a0eee2025-12-03WarningsName fallback
generic name: ALCOHOL
Smart Care Hand Sanitizer 3pk - Classic Men (Ocean/Sandalwood/Cedar and cypress)ALCOHOLShenzhen Lantern Scicence Co.,Ltd.451711f3-3b22-5d39-e063-6294a90a78942025-12-03WarningsName fallback
generic name: ALCOHOL
Smart Care Hand Sanitizer 3pk (Pistachio Brulee / Vanilla Shea /Caramel Honey)ALCOHOLShenzhen Lantern Scicence Co.,Ltd.4518038c-04ac-0fbe-e063-6294a90a7c322025-12-03WarningsName fallback
generic name: ALCOHOL
AMORA Spray. Hand Sanitizer WatermelonALCOHOLLongway Technology(Guangzhou) Co., Ltd.-44fc6694-2933-8700-e063-6294a90a274f2025-12-02WarningsName fallback
generic name: ALCOHOL
AMORA Spray. Hand Sanitizer coconutALCOHOLLongway Technology(Guangzhou) Co., Ltd.44fcf3d3-439b-7869-e063-6294a90a19c32025-12-02WarningsName fallback
generic name: ALCOHOL
B-Pure Hand Sanitizer Spray, Palm Sugar Pineapple ScentedALCOHOLFourstar Group USA, Inc.616c5315-690e-437f-b348-24754d9a23462025-12-02WarningsName fallback
generic name: ALCOHOL
B-Pure Hand SanitizerTropical Burst ScentedALCOHOLFourstar Group USA, Inc.67fe2f38-ed73-4fe7-9056-fa87f73004032025-12-02WarningsName fallback
generic name: ALCOHOL
B-Pure Moisturizing Hand Sanitizer Moonlight Orchid ScentedALCOHOLFourstar Group USA, Inc.4717e3d9-e10c-40d5-9903-af4087e1577b2025-12-02WarningsName fallback
generic name: ALCOHOL
B-Pure Moisturizing Hand Sanitizer with Collagen Sunset Breeze ScentedALCOHOLFourstar Group USA, Inc.81dc3ca5-9ad7-47f6-8c4b-0a9920c9d59c2025-12-02WarningsName fallback
generic name: ALCOHOL
B-Pure Moisturizing Hand Sanitizer with Hyaluronic Acid Peach Fizz ScentedALCOHOLFourstar Group USA, Inc.12e3d1b9-6c09-4e5a-8bd8-a7f90e806d242025-12-02WarningsName fallback
generic name: ALCOHOL
MedPride Instant SanitizerALCOHOLSHIELD LINE LLCa1c87c06-d4d2-cd0f-e053-2995a90a4eaa2025-12-02WarningsName fallback
generic name: ALCOHOL
Smart Care Hand Sanitizer Caramel HoneyALCOHOLShenzhen Lantern Scicence Co.,Ltd.450401c9-2098-9a23-e063-6394a90a20842025-12-02WarningsName fallback
generic name: ALCOHOL
AMORA Spray. Hand Sanitizer CherryALCOHOLLongway Technology(Guangzhou) Co., Ltd.44e04959-a21e-ba62-e063-6394a90a71922025-12-01WarningsName fallback
generic name: ALCOHOL
Hand Sanitizing WipeALCOHOLNeatGoods LLCb700ff10-2836-7893-e053-2995a90a43222025-12-01WarningsName fallback
generic name: ALCOHOL
Hand SanitizerALCOHOLNeatGoods LLCf7584f1a-e459-98f9-e053-6394a90a87922025-12-01WarningsName fallback
generic name: ALCOHOL

Reported adverse events (FAERS/openFDA)#

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