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 9 of 83 · 1,660 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Family Beauty Hydrating Hand Sanitizer, Strawberry ScentedALCOHOLFamily Dollar Stores, Inc.4c1b758e-30a2-42b9-a944-979bff34c5c92026-06-29WarningsName fallback
generic name: ALCOHOL
VQ Hydrating Hand Sanitizer Fresh WatermelonALCOHOLTychea Co.3afe45fa-32eb-0ff5-e063-6394a90a7fc32026-06-29WarningsName fallback
generic name: ALCOHOL
COCONUT ANTIBACTERIAL HAND SANITIZERALCOHOLENCHANTE ACCESSORIES INC.270dcb5d-113b-4278-b61e-a8808846c8952026-06-27WarningsName fallback
generic name: ALCOHOL
ORANGE CITRUS ANTIBACTERIAL HAND SANITIZERALCOHOLENCHANTE ACCESSORIES INC.86b77b42-53a1-4f9f-a607-18b1ddc04c442026-06-27WarningsName fallback
generic name: ALCOHOL
Anti Bacterial Hand Gel Pumpkin CarvingALCOHOLBath & Body Works, Inc.38e20b39-a453-7fb3-e063-6394a90aec9f2026-06-26WarningsName fallback
generic name: ALCOHOL
Anti Bacterial Hand Gel Dazzling DiamondALCOHOLBath & Body Works, Inc.43543448-20b6-3fff-e063-6294a90a6da02026-06-26WarningsName fallback
generic name: ALCOHOL
Anti Bacterial Hand Gel Island MargaritaALCOHOLBath & Body Works, Inc.38e1d9e9-08e9-3908-e063-6294a90adf6b2026-06-26WarningsName fallback
generic name: ALCOHOL
Anti-BacterialHandSpray Blush PetalsALCOHOLBath & Body Works, Inc.552fa251-6e0e-ce9f-e063-6394a90a14e12026-06-26WarningsName fallback
generic name: ALCOHOL
Anti-BacterialHandSpray Waikiki Beach CoconutALCOHOLBath & Body Works, Inc.552f9bc7-3158-a502-e063-6294a90a2d712026-06-26WarningsName fallback
generic name: ALCOHOL
Anti-BacterialHandSpray Malibu MistALCOHOLBath & Body Works, Inc.552f9e7b-b278-ce3a-e063-6394a90ae9ab2026-06-26WarningsName fallback
generic name: ALCOHOL
Anti-BacterialHandSpray Japanese Cherry BlossomALCOHOLBath & Body Works, Inc.552fa3e5-00b8-3825-e063-6294a90a1b0b2026-06-26WarningsName fallback
generic name: ALCOHOL
Anti-BacterialHandSpray Guava GlowALCOHOLBath & Body Works, Inc.552f9e7b-b275-ce3a-e063-6394a90ae9ab2026-06-26WarningsName fallback
generic name: ALCOHOL
Anti-BacterialHandSpray Strawberry BiteALCOHOLBath & Body Works, Inc.552f9cd1-3597-e2aa-e063-6294a90a82192026-06-26WarningsName fallback
generic name: ALCOHOL
Anti-BacterialHandSpray In The StarsALCOHOLBath & Body Works, Inc.552fa1b9-497c-cde8-e063-6394a90a89b52026-06-26WarningsName fallback
generic name: ALCOHOL
Anti-BacterialHandSpray Japanese Cherry BlossomALCOHOLBath & Body Works, Inc.552f95c9-e6e0-a1d7-e063-6294a90a83d62026-06-26WarningsName fallback
generic name: ALCOHOL
Anti-BacterialHandSpray Fresh WatermelonALCOHOLBath & Body Works, Inc.552f9bc7-3159-a502-e063-6294a90a2d712026-06-26WarningsName fallback
generic name: ALCOHOL
Anti-BacterialHandSpray Vanilla WhipALCOHOLBath & Body Works, Inc.552fa700-4214-d614-e063-6394a90aa12f2026-06-26WarningsName fallback
generic name: ALCOHOL
Anti Bacterial Hand Gel Disney Princess BelleALCOHOLBath & Body Works, Inc.552fbc4a-1f6c-d72a-e063-6294a90aebb22026-06-26WarningsName fallback
generic name: ALCOHOL
Anti Bacterial Hand Gel The Mandalorian and Grogu Bounty HunterALCOHOLBath & Body Works, Inc.552fbc4a-1f6b-d72a-e063-6294a90aebb22026-06-26WarningsName fallback
generic name: ALCOHOL
Anti Bacterial Hand Gel Pink Berry BurstALCOHOLBath & Body Works, Inc.552fc4da-f249-e88a-e063-6394a90ae2ab2026-06-26WarningsName fallback
generic name: ALCOHOL

Reported adverse events (FAERS/openFDA)#

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