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 72 of 82 · 1,638 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Aire-Master Waterless Hand SanitizerALCOHOLWhisk Products, Inc.8f0b77b1-ef16-4a3c-874b-07f78d6a45b72023-12-07WarningsName fallback
generic name: ALCOHOL
Septihol Hand SanitizerALCOHOLSTERIS Corporation279c5c6f-bf45-499f-a5a2-ddb5353821462023-12-06WarningsName fallback
generic name: ALCOHOL
ALCOHOL ANTISEPTIC HAND SANITIZERALCOHOLCustom Quest, Inc.70dd10e3-1958-43a6-af7e-29ca900b00f62023-12-04WarningsName fallback
generic name: ALCOHOL
AZX Wellness Hand SanitizerALCOHOLASC Marketing LTDb57c7e3a-f0bf-fd42-e053-2a95a90a3b4f2023-12-01WarningsName fallback
generic name: ALCOHOL
Instant Hand SanitizerALCOHOLASC Marketing LTDb57c8ae8-dfb1-a959-e053-2995a90abddf2023-12-01WarningsName fallback
generic name: ALCOHOL
Antibacterial Hand SanitizerALCOHOLASC Marketing LTDb56d6034-cac2-a9e2-e053-2a95a90aebf02023-12-01WarningsName fallback
generic name: ALCOHOL
Antibacterial Hand SanitizerALCOHOLASC Marketing LTDb56dc975-af3c-fdbe-e053-2a95a90a647b2023-12-01WarningsName fallback
generic name: ALCOHOL
AZX Wellness Hand SanitizerALCOHOLASC Marketing LTDbf0098ab-6c0d-ecd2-e053-2a95a90a670c2023-12-01WarningsName fallback
generic name: ALCOHOL
Zany Antiseptic GelALCOHOLLaboratorios Zepol S.A.ee085cb5-0ebf-498c-b622-b2c29d34bb9b2023-12-01WarningsName fallback
generic name: ALCOHOL
B-Pure Citrus scented Hand SanitizingALCOHOLFourstar Group USA, Inc.809f18fa-46ad-4366-bb76-96ab0e787ded2023-11-30WarningsName fallback
generic name: ALCOHOL
B-Pure Lavender Scented Hand SanitizerALCOHOLFourstar Group USA, Inc.5ca7c520-d099-4900-9e37-7f624397e5782023-11-30WarningsName fallback
generic name: ALCOHOL
B-Pure Citrus Scented Hand SanitizerALCOHOLFourstar Group USA, Inc.0a22230e-d511-041d-e063-6394a90aade92023-11-30WarningsName fallback
generic name: ALCOHOL
Unscented Hand SanitizerALCOHOLRaining Rosef706620b-15b3-4468-e053-6394a90a83172023-11-30WarningsName fallback
generic name: ALCOHOL
Unscented Hand SanitizerALCOHOLRaining Rosef7070892-741f-e528-e053-6294a90aee7a2023-11-30WarningsName fallback
generic name: ALCOHOL
Unscented Hand SanitizerALCOHOLRaining Rosef707644e-aa2c-d80a-e053-6394a90a33312023-11-30WarningsName fallback
generic name: ALCOHOL
Coconut Scented Hand SanitizerALCOHOLFOURSTAR GROUP USA, INC.95d41ada-68fc-44bf-bf34-1904d5b0dc452023-11-29WarningsName fallback
generic name: ALCOHOL
Natural Extensions Fragrance- Free Instant Hand SanitizerALCOHOLBenco Dentalb1f10f16-8269-402a-9646-32dbfdef1ffc2023-11-28WarningsName fallback
generic name: ALCOHOL
Zogics Instant Hand Sanitizer Hydrating GelALCOHOLZogics, LLC29c5f277-7b8a-4f38-8a09-33139f27c9102023-11-28WarningsName fallback
generic name: ALCOHOL
Alcohol WipesALCOHOLShaoxing Elite Bio-Tech Co.,Ltd.b42c2735-ead2-4db9-e053-2a95a90a229f2023-11-22WarningsName fallback
generic name: ALCOHOL
AntiBacterialHandSpray Vampire BloodALCOHOLBath & Body Works, Inc.0aac0b96-e477-173c-e063-6294a90a9a162023-11-21WarningsName fallback
generic name: ALCOHOL

Reported adverse events (FAERS/openFDA)#

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