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 73 of 82 · 1,638 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
B-Pure Coconut Scented Hand SanitizingALCOHOLFourstar Group USA, Inc.52b21789-d544-451e-b54a-4e2b4b85f4452023-11-21WarningsName fallback
generic name: ALCOHOL
B-Pure Lavender Scented Hand SanitizerALCOHOLFourstar Group USA, Inc.c82c37d7-d8fd-4411-a18f-fab4d1eaa2a92023-11-21WarningsName fallback
generic name: ALCOHOL
Antibacterial Hand SanitizerALCOHOLHit Promotional Productsa410e8a6-5c68-4358-a6ce-77d7a99ace792023-11-21WarningsName fallback
generic name: ALCOHOL
Antibacterial Hand SanitizerALCOHOLZhejiang Ayan Biotech Co.,Ltd.125fdc7c-fea3-4ced-8df2-0d35877df62d2023-11-21WarningsName fallback
generic name: ALCOHOL
AntiBacterialHandSpray Chasing FirefliesALCOHOLBath & Body Works, Inc.0a4a013d-b8bb-bd70-e063-6394a90aa9682023-11-16WarningsName fallback
generic name: ALCOHOL
AntiBacterialHandSpray Twisted PeppermintALCOHOLBath & Body Works, Inc.0a4a94e7-0310-df2c-e063-6394a90aff1a2023-11-16WarningsName fallback
generic name: ALCOHOL
AntiBacterialHandSpray Warm Vanilla SugarALCOHOLBath & Body Works, Inc.0a4a971d-6fd7-6cfb-e063-6294a90a678b2023-11-16WarningsName fallback
generic name: ALCOHOL
AntiBacterialHandSpray Winter Candy AppleALCOHOLBath & Body Works, Inc.0a4abed5-8b48-019b-e063-6394a90a42472023-11-16WarningsName fallback
generic name: ALCOHOL
AntiBacterialHandSpray Sweater WeatherALCOHOLBath & Body Works, Inc.0a4a971d-6fd0-6cfb-e063-6294a90a678b2023-11-16WarningsName fallback
generic name: ALCOHOL
AntiBacterialHandSpray Purrfect PumpkinALCOHOLBath & Body Works, Inc.0a4acfb6-75cd-0632-e063-6394a90af27b2023-11-16WarningsName fallback
generic name: ALCOHOL
AntiBacterialHandSpray Afternoon Apple PickingALCOHOLBath & Body Works, Inc.0a363bae-0d78-632e-e063-6394a90ac9ea2023-11-15WarningsName fallback
generic name: ALCOHOL
DOCTORS TOUCH Hand SanitizerALCOHOLDOCTOR'S CHOICE MEDICAL, LLCfc169526-75c4-4451-8f2b-ef04dda3e3d62023-11-11WarningsName fallback
generic name: ALCOHOL
LEMONBELLA Lavender Hand SanitizerALCOHOLLemonbella LLC98450cde-bfc9-4868-be45-6459e1c5e11f2023-11-11WarningsName fallback
generic name: ALCOHOL
GeriGentle Hand WipesALCOHOLGeri-Gentle Corporation278b23f5-c3bd-48ae-8c8d-d537d521e0a42023-11-10WarningsName fallback
generic name: ALCOHOL
TenderSant Hand SanitizerALCOHOLGeri-Gentle Corporation35966b11-756d-4156-8f5a-9bec1a5e11bb2023-11-10WarningsName fallback
generic name: ALCOHOL
Hand SanitizerALCOHOLDegasa, S.A. de C.V.cb2da26b-7ffe-485b-afc9-96fa9e5b80c72023-11-09WarningsName fallback
generic name: ALCOHOL
Antiseptic Hand SanitizerALCOHOLBeauty Partners LLC44e56110-da9b-4dde-b264-09a9f09a394b2023-11-08WarningsName fallback
generic name: ALCOHOL
Antibacterial Hand SanitizerALCOHOLZhejiang Ayan Biotech Co.,Ltd.9c56a823-bf7a-3005-e053-2a95a90a22e32023-11-06WarningsName fallback
generic name: ALCOHOL
Antibacterial Hand SanitizerALCOHOLZhejiang Ayan Biotech Co.,Ltd.9c574647-161d-6459-e053-2995a90a44702023-11-06WarningsName fallback
generic name: ALCOHOL
Antibacterial Hand SanitizerALCOHOLZhejiang Ayan Biotech Co.,Ltd.9c56afa2-c06c-fa03-e053-2995a90a74372023-11-06WarningsName fallback
generic name: ALCOHOL

Reported adverse events (FAERS/openFDA)#

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