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 7 of 83 · 1,660 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
B-Pure Moisturizing Hand Sanitizer Raspberry Silk ScentedALCOHOLFourstar Group USA, Inc.5f104a2c-a77b-47f0-abb1-69e9a8b8e0da2026-07-16WarningsName fallback
generic name: ALCOHOL
B-Pure Moisturizing Hand Sanitizer Pink Berry Pop ScentedALCOHOLFourstar Group USA, Inc.51404513-fe1c-4456-995f-eb1f6df282262026-07-16WarningsName fallback
generic name: ALCOHOL
B-Pure Moisturizing Hand Sanitizer Pink Passionfruit ScentedALCOHOLFourstar Group USA, Inc.c7b7c7d8-5e38-47cb-a508-cc9054e147ef2026-07-16WarningsName fallback
generic name: ALCOHOL
B-Pure Moisturizing Hand Sanitizer Sandy Sunset ScentedALCOHOLFourstar Group USA, Inc.e8dc6d52-eade-4c29-b27a-174d21065f8c2026-07-16WarningsName fallback
generic name: ALCOHOL
Aire-Master Foaming Hand Sanitizer Fragrance FreeALCOHOLWhisk Products, Inc.1c2915e1-6a95-4eab-afaa-82e41fd777902026-07-16WarningsName fallback
generic name: ALCOHOL
Ashley Belle Moisturizing Hand Sanitizer Apple SplashALCOHOLMy Imports USA LLCf9113d29-64d7-40fe-986e-7541273a40202026-07-15WarningsName fallback
generic name: ALCOHOL
Ashley Belle Moisturizing Hand Sanitizer Berry CremeALCOHOLMy Imports USA LLC66801907-4803-4108-9e82-20fb1562686b2026-07-15WarningsName fallback
generic name: ALCOHOL
Ashley Belle Moisturizing Hand Sanitizer Beach SandalwoodALCOHOLMy Imports USA LLC4ccaffc1-e9db-4960-96fe-c40cc6ba03992026-07-15WarningsName fallback
generic name: ALCOHOL
Ashley Belle Moisturizing Hand Sanitizer Confetti CupcakeALCOHOLMy Imports USA LLCbfca1984-ad8d-4832-90e2-1adc0586fb042026-07-15WarningsName fallback
generic name: ALCOHOL
Ashley Belle Moisturizing Hand Sanitizer Gingerbread CakeALCOHOLMy Imports USA LLCca1acaae-6273-44c7-9dd9-5809c6eb37f52026-07-15WarningsName fallback
generic name: ALCOHOL
Ashley Belle Moisturizing Hand Sanitizer Sugared PlumALCOHOLMy Imports USA LLCddc8e3eb-b3d0-4898-a448-e74eb3e484ac2026-07-15WarningsName fallback
generic name: ALCOHOL
Ashley Belle Moisturizing Hand Sanitizer Amber GlowALCOHOLMy Imports USA LLC6cc64f29-1ad4-4ab9-aeff-e0966f27c48e2026-07-15WarningsName fallback
generic name: ALCOHOL
Ashley Belle Moisturizing Hand Sanitizer PumpkinALCOHOLMy Imports USA LLC53ee6f2f-b898-4b0b-bc29-7757e9a1f2482026-07-15WarningsName fallback
generic name: ALCOHOL
Ashley Belle Moisturizing Hand Sanitizer Pistachio GlowALCOHOLMy Imports USA LLCa4e84f2f-b389-4ba7-9e18-33bd9b07825e2026-07-15WarningsName fallback
generic name: ALCOHOL
Ashley Belle Moisturizing Hand Sanitizer Matcha MistALCOHOLMy Imports USA LLC1cd01693-ef98-406e-af3a-499900d16d832026-07-15WarningsName fallback
generic name: ALCOHOL
Ashley Belle Moisturizing Hand Sanitizer Autumn Berry CrumbleALCOHOLMy Imports USA LLC42648f20-8666-4fdd-964d-8961ee71b4952026-07-15WarningsName fallback
generic name: ALCOHOL
Ashley Belle Moisturizing Hand Sanitizer White Tea BlossomALCOHOLMy Imports USA LLC7ab834ef-a2f2-410a-92af-fb2cbcf845a32026-07-15WarningsName fallback
generic name: ALCOHOL
Ashley Belle Moisturizing Hand Sanitizer Aloe Cucumber MistALCOHOLMy Imports USA LLCabba3e7f-e79f-4c37-91dd-9e9aaf0a97f52026-07-15WarningsName fallback
generic name: ALCOHOL
Ashley Belle Moisturizing Hand Sanitizer Sea Salt AirALCOHOLMy Imports USA LLCcbecb4d1-d00a-439f-9d10-910b47c216ca2026-07-15WarningsName fallback
generic name: ALCOHOL
Scentfull Hand Sanitizer Pink ChampagneALCOHOLScent Theory Products LLC565650e6-e5f9-c010-e063-6394a90aacfa2026-07-11WarningsName fallback
generic name: ALCOHOL

Reported adverse events (FAERS/openFDA)#

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