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 68 of 82 · 1,638 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Anti Bacterial Hand Gel Endless WeekendALCOHOLBath & Body Works, Inc.1a8ee169-fec2-d98a-e063-6294a90a19792024-06-10WarningsName fallback
generic name: ALCOHOL
Anti Bacterial Hand Gel Eucalyptus RainALCOHOLBath & Body Works, Inc.1a8f680b-ab3f-a550-e063-6394a90ac9512024-06-10WarningsName fallback
generic name: ALCOHOL
HAND SANITIZER COCONUT BREEZEALCOHOLSCENT THEORY PRODUCTS LLC1a5152b3-d674-f69a-e063-6394a90a6cac2024-06-07WarningsName fallback
generic name: ALCOHOL
HAND SANITIZER REBEL CHERRYALCOHOLSCENT THEORY PRODUCTS LLC1a503858-4d2f-8e32-e063-6294a90ade972024-06-07WarningsName fallback
generic name: ALCOHOL
b pure Hydrating Hand Sanitizer Salted Caramel ScentedALCOHOLFOURSTAR GROUP USA, INC.1a38e171-e2fb-206c-e063-6294a90ac6382024-06-06WarningsName fallback
generic name: ALCOHOL
b pure Hydrating Hand Sanitizer Caramel Apple ScentedALCOHOLFOURSTAR GROUP USA, INC.1a38d19b-7c00-1c2b-e063-6394a90a4caa2024-06-06WarningsName fallback
generic name: ALCOHOL
Anti Bacterial Hand Gel Calypso ClementineALCOHOLBath & Body Works, Inc.1a25084f-b8d7-1188-e063-6294a90a1e962024-06-05WarningsName fallback
generic name: ALCOHOL
Anti Bacterial Hand Gel Candy Apple CauldronALCOHOLBath & Body Works, Inc.1a251228-7fda-5a38-e063-6294a90a5d082024-06-05WarningsName fallback
generic name: ALCOHOL
Anti Bacterial Hand Gel Champagne Apple and HoneyALCOHOLBath & Body Works, Inc.1a252344-cf76-752e-e063-6294a90a010f2024-06-05WarningsName fallback
generic name: ALCOHOL
Anti Bacterial Hand Gel Chasing DaydreamsALCOHOLBath & Body Works, Inc.1a25aac4-34f8-0371-e063-6294a90ac0822024-06-05WarningsName fallback
generic name: ALCOHOL
Anti Bacterial Hand Gel Coffee and WhiskeyALCOHOLBath & Body Works, Inc.1a25de73-8740-c98d-e063-6394a90afffb2024-06-05WarningsName fallback
generic name: ALCOHOL
Anti Bacterial Hand Gel Crystal Blue CoastALCOHOLBath & Body Works, Inc.1a25f084-5228-b3ef-e063-6294a90a98822024-06-05WarningsName fallback
generic name: ALCOHOL
Anti Bacterial Hand Gel Brightest BloomALCOHOLBath & Body Works, Inc.1a128ecb-230f-0882-e063-6294a90a41372024-06-04WarningsName fallback
generic name: ALCOHOL
Anti Bacterial Hand Gel Brown Sugar Toaster TreatALCOHOLBath & Body Works, Inc.1a12d9ca-fec4-2adc-e063-6394a90ab1812024-06-04WarningsName fallback
generic name: ALCOHOL
Anti Bacterial Hand Gel ButterflyALCOHOLBath & Body Works, Inc.1a12dbf3-2d95-291c-e063-6394a90a1efd2024-06-04WarningsName fallback
generic name: ALCOHOL
Hand SanitizerALCOHOLJIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.dbfdecf0-a961-4cc5-bf87-ae30bbc302dd2024-05-31WarningsName fallback
generic name: ALCOHOL
hand sanitizer 01ALCOHOLCosmuses Cosmetics (Ningbo) Co., Ltd.19a6c3c6-4b27-9011-e063-6394a90ae5122024-05-30WarningsName fallback
generic name: ALCOHOL
antibacterial hand sanitizer gel 01ALCOHOLCosmuses Cosmetics (Ningbo) Co., Ltd.19a7b2fc-239c-b53c-e063-6394a90a09062024-05-30WarningsName fallback
generic name: ALCOHOL
Anti Bacterial Hand Gel Beautiful DayALCOHOLBath & Body Works, Inc.19858fde-3697-1263-e063-6394a90a1c252024-05-28WarningsName fallback
generic name: ALCOHOL
Anti Bacterial Hand Gel Blackberries and BasilALCOHOLBath & Body Works, Inc.19861b01-1595-6863-e063-6294a90a147f2024-05-28WarningsName fallback
generic name: ALCOHOL

Reported adverse events (FAERS/openFDA)#

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