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 24 of 83 · 1,660 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Anti Bacterial Hand Gel Pumpkin AppleALCOHOLBath & Body Works, Inc.4690812f-0f94-a899-e063-6394a90af6b92026-03-10WarningsName fallback
generic name: ALCOHOL
Anti Bacterial Hand Gel Firecracker PopALCOHOLBath & Body Works, Inc.38e21dcc-ea88-c6cd-e063-6294a90a057e2026-03-09WarningsName fallback
generic name: ALCOHOL
Anti Bacterial Hand Gel Eucalyptus and SpearmintALCOHOLBath & Body Works, Inc.1a8f680b-ab3e-a550-e063-6394a90ac9512026-03-09WarningsName fallback
generic name: ALCOHOL
Anti Bacterial Hand Gel In The StarsALCOHOLBath & Body Works, Inc.1ab8735e-1481-040c-e063-6394a90aff9b2026-03-09WarningsName fallback
generic name: ALCOHOL
Anti Bacterial Hand Gel OceanALCOHOLBath & Body Works, Inc.1ba6a47e-b5e2-eda2-e063-6294a90a0a682026-03-09WarningsName fallback
generic name: ALCOHOL
Anti Bacterial Hand Gel Black Cherry MerlotALCOHOLBath & Body Works, Inc.1ba69e88-401b-2aa4-e063-6294a90a79d12026-03-09WarningsName fallback
generic name: ALCOHOL
Anti Bacterial Hand Gel Cozy Vanilla AlmondALCOHOLBath & Body Works, Inc.1ba6a804-b4b2-2b4c-e063-6294a90ac4f12026-03-09WarningsName fallback
generic name: ALCOHOL
Anti Bacterial Hand Gel Crisp Morning AirALCOHOLBath & Body Works, Inc.1bba88b3-3d5b-ad96-e063-6294a90aa4f32026-03-09WarningsName fallback
generic name: ALCOHOL
Anti Bacterial Hand Gel Sea and SandstoneALCOHOLBath & Body Works, Inc.1bbaa2b3-9322-9aab-e063-6394a90a14c92026-03-09WarningsName fallback
generic name: ALCOHOL
Anti Bacterial Hand Gel White Tea and SageALCOHOLBath & Body Works, Inc.1bba9834-3c88-f5af-e063-6394a90aa6bd2026-03-09WarningsName fallback
generic name: ALCOHOL
Anti Bacterial Hand Gel Pineapple MangoALCOHOLBath & Body Works, Inc.38e09999-3473-2e4c-e063-6394a90a4b5d2026-03-09WarningsName fallback
generic name: ALCOHOL
Anti Bacterial Hand Gel Mahogany TeakwoodALCOHOLBath & Body Works, Inc.1bba8dfa-947c-1ee2-e063-6294a90ae52a2026-03-09WarningsName fallback
generic name: ALCOHOL
Anti Bacterial Hand Gel Strawberry Pound CakeALCOHOLBath & Body Works, Inc.1bba8dfa-947f-1ee2-e063-6294a90ae52a2026-03-09WarningsName fallback
generic name: ALCOHOL
Anti Bacterial Hand Gel A Thousand WishesALCOHOLBath & Body Works, Inc.29a539bb-42e3-dc73-e063-6394a90a5fe92026-03-09WarningsName fallback
generic name: ALCOHOL
Anti Bacterial Hand Gel Peach BelliniALCOHOLBath & Body Works, Inc.2b1124a3-9b14-07b6-e063-6394a90a49732026-03-09WarningsName fallback
generic name: ALCOHOL
Anti Bacterial Hand Gel Watermelon LemonadeALCOHOLBath & Body Works, Inc.38e1bd3f-8e6e-7b68-e063-6394a90a82742026-03-09WarningsName fallback
generic name: ALCOHOL
Anti Bacterial Hand Gel Sunshine and LemonsALCOHOLBath & Body Works, Inc.1bba8dfa-9481-1ee2-e063-6294a90ae52a2026-03-09WarningsName fallback
generic name: ALCOHOL
Anti Bacterial Hand Gel Midnight Blue CitrusALCOHOLBath & Body Works, Inc.2b116b79-fe71-325a-e063-6394a90a045b2026-03-09WarningsName fallback
generic name: ALCOHOL
Anti Bacterial Hand Gel Warm Vanilla SugarALCOHOLBath & Body Works, Inc.38d6f6a0-52bf-df77-e063-6394a90a44642026-03-09WarningsName fallback
generic name: ALCOHOL
Anti Bacterial Hand Gel Crystal Blue CoastALCOHOLBath & Body Works, Inc.38e1480e-d217-7b66-e063-6394a90abfe52026-03-09WarningsName fallback
generic name: ALCOHOL

Reported adverse events (FAERS/openFDA)#

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