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 29 of 83 · 1,660 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Anti Bacterial Moisturizing Hand Sanitizer Blueberry BelliniALCOHOLBath & Body Works, Inc.387c9fca-3d39-2553-e063-6394a90a922d2026-03-02WarningsName fallback
generic name: ALCOHOL
Anti Bacterial Moisturizing Hand Sanitizer Strawbery KiwiALCOHOLBath & Body Works, Inc.29a24b5e-fbef-bb91-e063-6294a90af5322026-03-02WarningsName fallback
generic name: ALCOHOL
Anti Bacterial Moisturizing Hand Sanitizer Beautiful DayALCOHOLBath & Body Works, Inc.387ca6e9-38eb-2519-e063-6394a90a42112026-03-02WarningsName fallback
generic name: ALCOHOL
Anti Bacterial Moisturizing Hand Sanitizer Iced Lemon Pound CakeALCOHOLBath & Body Works, Inc.387ca6e9-38ec-2519-e063-6394a90a42112026-03-02WarningsName fallback
generic name: ALCOHOL
Anti Bacterial Moisturizing Hand Sanitizer Rose Water and IvyALCOHOLBath & Body Works, Inc.387caf6b-fd9c-a63f-e063-6294a90a041a2026-03-02WarningsName fallback
generic name: ALCOHOL
Anti Bacterial Moisturizing Hand Sanitizer Fresh Coconut and CottonALCOHOLBath & Body Works, Inc.29a27bb2-2edd-6e6d-e063-6394a90a4fb22026-03-02WarningsName fallback
generic name: ALCOHOL
Anti Bacterial Moisturizing Hand Sanitizer Pomegranate and BlackberryALCOHOLBath & Body Works, Inc.387ca290-1d8a-abb7-e063-6294a90a12ff2026-03-02WarningsName fallback
generic name: ALCOHOL
Anti Bacterial Moisturizing Hand Sanitizer Afternoon Apple PickingALCOHOLBath & Body Works, Inc.369ac581-c59b-4eb5-e063-6394a90aec7a2026-03-02WarningsName fallback
generic name: ALCOHOL
AlcoholALCOHOLThe Kroger Co.a848de11-0438-400b-b363-df595692685a2026-02-27Warnings, Adverse reactionsName fallback
generic name: ALCOHOL
AlcoholALCOHOLThe Kroger Co.163b479b-aa0f-4174-8dfb-ac33bd07752a2026-02-27Warnings, Adverse reactionsName fallback
generic name: ALCOHOL
Hand SanitizerALCOHOLWalmart Inc.2112ba04-1584-46dd-9a7b-2dfd27e501b72026-02-27Warnings, Adverse reactionsName fallback
generic name: ALCOHOL
Avant Original - Fragrance FreeALCOHOLB4 Soap LLC35a2d0ba-9209-4d70-b3b4-537225f83c842026-02-26WarningsName fallback
generic name: ALCOHOL
Scent Theory Hand Sanitizers Cherry Pop, Ocean Splash, Juicy PearALCOHOLScent Theory Products LLC4b865d82-71c3-1023-e063-6294a90ac7742026-02-23WarningsName fallback
generic name: ALCOHOL
Advanced Hand SanitizerALCOHOLChain Drug Marketing Associationa85d93f2-e6f0-4fad-9ff7-6cbb62942bb22026-02-19Warnings, Adverse reactionsName fallback
generic name: ALCOHOL
Anti-BacterialHandSpray Eucalyptus and SpearmintALCOHOLBath & Body Works, Inc.38d5ca92-2518-3dc4-e063-6394a90a2bc02026-02-19WarningsName fallback
generic name: ALCOHOL
AlcoholALCOHOLMeijer, Inc.dd0bf473-b036-4a72-8caf-d9624d840fad2026-02-19Warnings, Adverse reactionsName fallback
generic name: ALCOHOL
AlcoholALCOHOLMeijer, Inc.6f6db114-c474-4b4b-971f-01743850cf3c2026-02-19Warnings, Adverse reactionsName fallback
generic name: ALCOHOL
PDI Alcohol Prep Pad Sterile Large and MediumALCOHOLProfessional Disposables International Inc8fe9cf1c-3f5f-4873-9648-6d4c79f8cf032026-02-18WarningsName fallback
generic name: ALCOHOL
Travel Wipes Fresh Citrus ScentALCOHOLSINGULAR ENTERPRISES LLCea77be5e-7c69-4787-b39a-4753b002dbbd2026-02-18WarningsName fallback
generic name: ALCOHOL
Antibacterial Hand SanitizerALCOHOLS. P. Richards Company8d88285b-83d5-4089-bb8d-839537ae06f52026-02-18Warnings, Adverse reactionsName fallback
generic name: ALCOHOL

Reported adverse events (FAERS/openFDA)#

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