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 54 of 82 · 1,638 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Instant Hand SanitizerALCOHOLHenry Schein, Inc.e80feb63-2c51-4164-806d-778e39e620e82025-01-10WarningsName fallback
generic name: ALCOHOL
Instant Hand SanitizerALCOHOLHenry Schein, Inc.3b075cdc-509d-4259-99a2-0e219998949d2025-01-10WarningsName fallback
generic name: ALCOHOL
Hand Guard Foaming Alcohol Instant Hand SanitizerALCOHOLWechem, Inc.2b60cd24-f0a9-5c54-e063-6394a90ab3502025-01-10WarningsName fallback
generic name: ALCOHOL
Dr Tichenors First Aid AntisepticALCOHOLDr. G. H. Tichenor's Antiseptic Company9947855d-b8e0-4c22-a627-16b526242e392025-01-09WarningsName fallback
generic name: ALCOHOL
Hand RecoveryALCOHOLDerma Glove074a760f-9031-40c1-9867-95ef0345418d2025-01-08WarningsName fallback
generic name: ALCOHOL
Hand SanitizerALCOHOLTempo Industries, Inc.af9a0d53-0d4a-6dc7-e053-2a95a90acc1c2025-01-08WarningsName fallback
generic name: ALCOHOL
Hand SanitizerALCOHOLTempo Industries, Inc.af9a678b-488a-7045-e053-2995a90a401c2025-01-08WarningsName fallback
generic name: ALCOHOL
PentaCleanse Alcohol WipesALCOHOLPrestige Care Pharmacy Ince41a3e03-af01-5280-e053-2a95a90a8afc2025-01-08WarningsName fallback
generic name: ALCOHOL
Instant Hand SanitizerALCOHOLWater-Jel Technologies54e62104-8076-41db-afe5-6dc5c3563acc2025-01-06WarningsName fallback
generic name: ALCOHOL
Anti Bacterial Hand Gel Gingerbread BakeryALCOHOLBath & Body Works, Inc.2b0f53e3-eb4c-a372-e063-6394a90ae5df2025-01-06WarningsName fallback
generic name: ALCOHOL
Anti Bacterial Hand Gel WinterALCOHOLBath & Body Works, Inc.2b0f4ddc-2384-3841-e063-6394a90aa2952025-01-06WarningsName fallback
generic name: ALCOHOL
Anti Bacterial Hand Gel Deep OceanALCOHOLBath & Body Works, Inc.2b0f3f65-746c-44ea-e063-6294a90a91852025-01-06WarningsName fallback
generic name: ALCOHOL
Anti Bacterial Hand Gel Pink Sparkling SpritzALCOHOLBath & Body Works, Inc.2b0f3ca1-0a65-08a6-e063-6294a90a9df22025-01-06WarningsName fallback
generic name: ALCOHOL
Anti Bacterial Hand Gel Paris AmourALCOHOLBath & Body Works, Inc.2b0f525b-ff65-9160-e063-6394a90a4cc12025-01-06WarningsName fallback
generic name: ALCOHOL
Anti Bacterial Hand Gel Fresh BalsamALCOHOLBath & Body Works, Inc.2b0f3ca1-0a64-08a6-e063-6294a90a9df22025-01-06WarningsName fallback
generic name: ALCOHOL
Anti Bacterial Hand Gel Perfect in PinkALCOHOLBath & Body Works, Inc.2b0f4b8f-b046-8f98-e063-6394a90ac9b72025-01-06WarningsName fallback
generic name: ALCOHOL
Anti Bacterial Hand Gel Twisted PeppermintALCOHOLBath & Body Works, Inc.2b0f4b8f-b041-8f98-e063-6394a90ac9b72025-01-06WarningsName fallback
generic name: ALCOHOL
Anti Bacterial Hand Gel Snowy Peach BerryALCOHOLBath & Body Works, Inc.2b0f466b-8e08-8f9c-e063-6394a90ae8ab2025-01-06WarningsName fallback
generic name: ALCOHOL
Anti Bacterial Hand Gel Champagne In ParisALCOHOLBath & Body Works, Inc.2b0f525b-ff63-9160-e063-6394a90a4cc12025-01-06WarningsName fallback
generic name: ALCOHOL
Anti Bacterial Hand Gel Lavender LuxeALCOHOLBath & Body Works, Inc.2b0f466b-8e0c-8f9c-e063-6394a90ae8ab2025-01-06WarningsName fallback
generic name: ALCOHOL

Reported adverse events (FAERS/openFDA)#

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