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 57 of 82 · 1,638 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Anti Bacterial Hand Gel Fresh RainfallALCOHOLBath & Body Works, Inc.29a54361-e107-20d7-e063-6294a90a117a2024-12-19WarningsName fallback
generic name: ALCOHOL
Anti Bacterial Hand Gel Pumpkin CupcakeALCOHOLBath & Body Works, Inc.29a53c91-0bda-f572-e063-6294a90ae8952024-12-19WarningsName fallback
generic name: ALCOHOL
Anti Bacterial Hand Gel Sweater WeatherALCOHOLBath & Body Works, Inc.29a540fd-60b7-eb1e-e063-6394a90a27f72024-12-19WarningsName fallback
generic name: ALCOHOL
Alcohol Antiseptic 70% Topical SolutionALCOHOLMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Incaa95e99f-5c17-c394-e053-2995a90a6bf92024-12-19WarningsName fallback
generic name: ALCOHOL
Thick Hand SanitizerALCOHOLMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inca35b4c26-469b-72ec-e053-2a95a90a05102024-12-19WarningsName fallback
generic name: ALCOHOL
EXTENDED CARE Foaming Hand SanitizerALCOHOLTRIPLE A SUPPLIES, INC.f244f9c0-82c6-42a8-b0a8-63af546ed26f2024-12-19WarningsName fallback
generic name: ALCOHOL
Anti Bacterial Hand Gel Cucumber MelonALCOHOLBath & Body Works, Inc.29a63c54-116f-30bb-e063-6394a90a8c6f2024-12-19WarningsName fallback
generic name: ALCOHOL
Anti Bacterial Hand Gel Frosted Coconut SnowballALCOHOLBath & Body Works, Inc.29a652a8-15fd-80d4-e063-6394a90acb4d2024-12-19WarningsName fallback
generic name: ALCOHOL
Anti Bacterial Hand Gel Black Cherry FrostALCOHOLBath & Body Works, Inc.29a654df-016b-830e-e063-6394a90a10622024-12-19WarningsName fallback
generic name: ALCOHOL
Anti Bacterial Hand Gel Winterberry IceALCOHOLBath & Body Works, Inc.29a64c95-eb54-8081-e063-6394a90a07262024-12-19WarningsName fallback
generic name: ALCOHOL
Anti Bacterial Hand Gel Magic In The AirALCOHOLBath & Body Works, Inc.29a651e4-a014-57d2-e063-6394a90a35f02024-12-19WarningsName fallback
generic name: ALCOHOL
Anti Bacterial Hand Gel Sweet Tea and LemonadeALCOHOLBath & Body Works, Inc.29a64de5-af39-5a91-e063-6394a90ac35c2024-12-19WarningsName fallback
generic name: ALCOHOL
Anti Bacterial Hand Gel Honolulu SunALCOHOLBath & Body Works, Inc.29a64c62-8517-1b39-e063-6294a90a35a82024-12-19WarningsName fallback
generic name: ALCOHOL
Anti Bacterial Hand Gel Strawberry SnowflakesALCOHOLBath & Body Works, Inc.29a651e4-a016-57d2-e063-6394a90a35f02024-12-19WarningsName fallback
generic name: ALCOHOL
Anti Bacterial Hand Gel Snowflakes and CashmereALCOHOLBath & Body Works, Inc.29a654df-0169-830e-e063-6394a90a10622024-12-19WarningsName fallback
generic name: ALCOHOL
RUBBING ALCOHOLALCOHOLINTERNATIONAL GENERAL TRADING CORPbd5ee961-1d64-0d9d-e053-2a95a90a60102024-12-18WarningsName fallback
generic name: ALCOHOL
RUBBING ALCOHOLALCOHOLINTERNATIONAL GENERAL TRADING CORPbd5eb0df-cd2d-691c-e053-2995a90a25112024-12-18WarningsName fallback
generic name: ALCOHOL
CVS Decolorized IodineALCOHOLCVS Pharmacyd9f1a1aa-f402-4c0d-96e8-eeb5eb5cfacd2024-12-18WarningsName fallback
generic name: ALCOHOL
Mary Kay Satin Hands Shea Hand SanitizerALCOHOLMary Kay Inc.b6c2b979-2940-1569-e053-2995a90a532c2024-12-17WarningsName fallback
generic name: ALCOHOL
Hand SanitizerALCOHOLNatures Formulae Health Products Ltd.a7da75b3-b55d-641c-e053-2995a90a43b72024-12-17WarningsName fallback
generic name: ALCOHOL

Reported adverse events (FAERS/openFDA)#

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