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 17 of 83 · 1,660 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Kleenex Ultra Moisturizing Hand SanitizerALCOHOLKimberly-Clark Corporation75e884bf-8e0d-41e7-adbb-4400ee3d1e072026-05-08WarningsName fallback
generic name: ALCOHOL
XHC-075ALCOHOLEcolab Inc.708d0018-372b-4fde-b408-f4be030f26632026-05-07WarningsName fallback
generic name: ALCOHOL
Hand SanitizerALCOHOLGiant Eagled384d3f3-a3c8-a98d-e053-2995a90ab9bf2026-05-07WarningsName fallback
generic name: ALCOHOL
Scentfull Hand Sanitizer Sea BreezeALCOHOLScent Theory Products LLC3cfac192-84c8-7897-e063-6294a90ae93d2026-05-06WarningsName fallback
generic name: ALCOHOL
Scentfull Hand Sanitizer Whipped CoconutALCOHOLScent Theory Products LLC3cfaadb3-1881-2dd9-e063-6394a90abcb42026-05-06WarningsName fallback
generic name: ALCOHOL
Scentfull Hand Sanitizer Pink ChampagneALCOHOLScent Theory Products LLC3cf7a910-28c8-bbe2-e063-6394a90aff732026-05-06WarningsName fallback
generic name: ALCOHOL
Kleenex Reveal Moisturizing Foam Hand SanitizerALCOHOLKimberly-Clark4a491f90-268e-470d-a74c-473f1efe7c8b2026-05-06WarningsName fallback
generic name: ALCOHOL
Boo Crew Hand Care Essentials Boo Berry, Pumpkin SpiceALCOHOLScent Theory Products LLC51143d5c-4cd0-0b2e-e063-6294a90a28312026-05-05WarningsName fallback
generic name: ALCOHOL
GuardALCOHOLApollo Health and Beauty Carefdc99948-1bd0-cdf2-e053-6394a90aaf972026-05-05WarningsName fallback
generic name: ALCOHOL
Scott Moisturizing Foam Hand SanitizerALCOHOLKimberly-Clark25900e62-c8fd-4942-ad38-4b99243084602026-05-05WarningsName fallback
generic name: ALCOHOL
AlcoholALCOHOLTARGET CORPORATION INC.092f6934-d697-2104-e063-6294a90a0b322026-05-04WarningsName fallback
generic name: ALCOHOL
Hand Sanitizer Lemon ScentedALCOHOLTaizhou Juheng Biotechnology Co., Ltd.21387234-0ac9-499d-97bf-90bccc4782ad2026-05-04WarningsName fallback
generic name: ALCOHOL
DD Mart Hand SanitizerALCOHOLApollo Health and Beauty Care0b1806c2-2469-0c81-e063-6394a90a3b2a2026-05-03WarningsName fallback
generic name: ALCOHOL
HIMARKALCOHOLApollo Health and Beauty Caref9658a02-e3fa-096a-e053-6294a90afb212026-05-03WarningsName fallback
generic name: ALCOHOL
Limited Edition Hand Sanitizer Golden Vanilla, Starlight Frost, Pink Satin ProseccoALCOHOLScent Theory Products LLC50f03829-eda8-3a25-e063-6294a90a6fd22026-05-03WarningsName fallback
generic name: ALCOHOL
EthanolALCOHOLTARGET CORPORATION INC.28ef35a8-e6ca-9669-e063-6394a90abf8f2026-05-03WarningsName fallback
generic name: ALCOHOL
Summit 375 Gel Alcohol Hand SanitizerALCOHOLR.L. Williams Company509cc442-09f8-d17f-e063-6394a90a77ea2026-04-29WarningsName fallback
generic name: ALCOHOL
B-Pure Moisturizing Hand Sanitizer Vanilla Creme ScentedALCOHOLFourstar Group USA, Inc.13faded0-7953-4d86-b952-e4bcf4ba53cc2026-04-28WarningsName fallback
generic name: ALCOHOL
B-Pure Moisturizing Hand Sanitizer Sweet Plum and Jasmine ScentedALCOHOLFourstar Group USA, Inc.450d025a-cc11-796e-e063-6394a90a7e5c2026-04-28WarningsName fallback
generic name: ALCOHOL
B-Pure Hand Sanitizer Coconut Vanilla ScentedALCOHOLFourstar Group USA, Inc.e179b21d-fb93-4671-87c0-b8ae094533282026-04-28WarningsName fallback
generic name: ALCOHOL

Reported adverse events (FAERS/openFDA)#

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