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 79 of 82 · 1,638 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SANITIZERALCOHOLBOZZANO Group8c598f92-334e-43e6-bba2-7de70b42c0c92023-10-26WarningsName fallback
generic name: ALCOHOL
hand sanitizerALCOHOLHygieia7dce9b6e-45ec-4006-ab82-998fb0b185bf2023-10-26WarningsName fallback
generic name: ALCOHOL
BANANA SCENT ANTI GERMALCOHOLF21 OpCo, LLCc96a97b2-b592-44f1-b9bd-fe60173967602023-10-26WarningsName fallback
generic name: ALCOHOL
Justice Cotton Candy Scented Anti-bacterial Hand Sanitizer CatALCOHOLTween Brands, Inc.5cc10046-bf5e-4e7d-9a22-46f667954c972023-10-26WarningsName fallback
generic name: ALCOHOL
QUR Vanilla essential oil hand sanitizerALCOHOLQur, Incbedae330-d82a-6843-e053-2a95a90ac9642023-10-26WarningsName fallback
generic name: ALCOHOL
Justice Grape Scented Anti bacterial Hand SanitizerALCOHOLTween Brands, Inc.d8dfd369-9a4e-46fd-9d8e-50634da552472023-10-26WarningsName fallback
generic name: ALCOHOL
Justice Cotton Candy Scented Anti bacterial Hand SanitizerALCOHOLTween Brands, Inc.2e900e90-a5f1-49b3-9268-643f0e2521002023-10-26WarningsName fallback
generic name: ALCOHOL
STRAWBERRY SCENT ANTI GERMALCOHOLF21 OpCo, LLC87c59ebd-1502-4cc6-ac01-8fe93808fbc12023-10-26WarningsName fallback
generic name: ALCOHOL
BERRY SCENT ANTI GERMALCOHOLF21 OpCo,LLC30de91f2-336f-453c-80b7-ecf32a1b3cb82023-10-26WarningsName fallback
generic name: ALCOHOL
QUR Lavender essential oil hand sanitizerALCOHOLQur, Incbedaa457-192c-3404-e053-2995a90ac3192023-10-26WarningsName fallback
generic name: ALCOHOL
ALOE VERA SCENT ANTI GERMALCOHOLF21 OpCo,LLCdd3c9039-4773-4268-85ff-58dd10433f332023-10-26WarningsName fallback
generic name: ALCOHOL
P b pure Antibacterial Hand Sanitizer Ocean Breeze ScentedALCOHOLFOURSTAR GROUP USA, INC.b17d3da6-a0f8-55d2-e053-2995a90a6ab92023-10-26WarningsName fallback
generic name: ALCOHOL
P b pure Antibacterial Hand Sanitizer Cucumber Melon ScentedALCOHOLFOURSTAR GROUP USA, INC.b17d5660-8514-b1dc-e053-2a95a90a0ac82023-10-26WarningsName fallback
generic name: ALCOHOL
Fresh Peach Scented Antibacterial Hand SanitizerALCOHOLFourstar Group USA, Inc.b3390527-82af-612d-e053-2995a90aafd92023-10-26WarningsName fallback
generic name: ALCOHOL
Sweet Pea Scented Antibacterial Hand SanitizerALCOHOLFourstar Group USA, Inc.b33937e3-1a55-f020-e053-2a95a90a86572023-10-26WarningsName fallback
generic name: ALCOHOL
Cucumber Melon Scented Antibacterial Hand SanitizerALCOHOLFourstar Group USA, Inc.b338dd92-0ace-2c9d-e053-2995a90a63ca2023-10-26WarningsName fallback
generic name: ALCOHOL
P b pure Antibacterial Hand Sanitizer Sweet Pea ScentedALCOHOLFOURSTAR GROUP USA, INC.b17d7c7c-c354-4554-e053-2a95a90a9e842023-10-26WarningsName fallback
generic name: ALCOHOL
Ocean Breeze Scented Antibacterial Hand SanitizerALCOHOLFourstar Group USA, Inc.b3391b8e-877f-e74a-e053-2995a90afd622023-10-26WarningsName fallback
generic name: ALCOHOL
Lavender scented anti-bacterial hand sanitizerALCOHOLFOURSTAR GROUP USA, INC.c54e85c6-3c3a-5c53-e053-2995a90ab7592023-10-26WarningsName fallback
generic name: ALCOHOL
Coconut and Lime Scented Hand SanitizerALCOHOLFOURSTAR GROUP USA, INC.c090752c-8a03-e19b-e053-2995a90a73702023-10-26WarningsName fallback
generic name: ALCOHOL

Reported adverse events (FAERS/openFDA)#

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