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 64 of 82 · 1,638 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sugar Cookie Sanitizer 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.1efc0e9e-b4eb-d2b0-e063-6394a90a77792024-08-06WarningsName fallback
generic name: ALCOHOL
Lemon Lime Hand Sanitizer Spray. 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.1efe7236-d7bd-2a1c-e063-6294a90a736e2024-08-06WarningsName fallback
generic name: ALCOHOL
WhiskCare 375 Fragrance FreeALCOHOLWhisk Products, Inc.c6787b12-ab90-4305-a6cc-55fd2c57cd2d2024-07-26WarningsName fallback
generic name: ALCOHOL
Shimmy Original Hand SanitizerALCOHOLShimmy Products LLCc4c135ed-3b6a-69c8-e053-2a95a90aad1c2024-07-25WarningsName fallback
generic name: ALCOHOL
Shimmy Rose Hibiscus Hand SanitizerALCOHOLShimmy Products LLCc50b5044-31fd-672a-e053-2995a90a49fc2024-07-25WarningsName fallback
generic name: ALCOHOL
Shimmy Meyer Lemon Hand SanitizerALCOHOLShimmy Products LLCc50b9543-e276-9052-e053-2a95a90a83252024-07-25WarningsName fallback
generic name: ALCOHOL
Shimmy Neutral Hand SanitizerALCOHOLShimmy Products LLCdf2761b9-0fca-5e2a-e053-2a95a90a9b8d2024-07-25WarningsName fallback
generic name: ALCOHOL
Symmetry Foaming Hand SanitizerALCOHOLBuckeye International, Inc.bcab4842-50ff-4c7f-8b85-0126f4b585b02024-07-23Warnings, Adverse reactionsName fallback
generic name: ALCOHOL
Altra Hand Sanitizer with Aloe and Vitamin EALCOHOLBuckeye International, Inc.a2974445-eaa3-d9f0-e053-2995a90a78fc2024-07-23WarningsName fallback
generic name: ALCOHOL
LAVENDER SCENTED HAND SANITIZER PENALCOHOLFourstar Group USA, Inc.5c27f212-4010-44de-9e9d-758ffdfcc5c12024-07-18WarningsName fallback
generic name: ALCOHOL
CITRUS SCENTED HAND SANITIZER PENALCOHOLFourstar Group USA, Incb3c59433-a4cd-42cb-9492-fcdc19ca765c2024-07-18WarningsName fallback
generic name: ALCOHOL
COCONUT SCENTED HAND SANITIZER PENALCOHOLFourstar Group USA, Inc.2fa53710-c084-48e0-8300-511d0d93a88d2024-07-18WarningsName fallback
generic name: ALCOHOL
b.pure Hand Sanitizer Lemon ScentedALCOHOLFOURSTAR GROUP USA, INC.bc35f9ec-e453-4994-91ae-2294d058e45d2024-07-12WarningsName fallback
generic name: ALCOHOL
b.pure Hand Sanitizer Watermelon ScentedALCOHOLFOURSTAR GROUP USA, INC.e0ed1b57-2d7e-4e63-96f5-dbbb2aef26df2024-07-12WarningsName fallback
generic name: ALCOHOL
b.pure Hand Sanitizer Green Apple ScentedALCOHOLFOURSTAR GROUP USA, INC.7c870d8f-c298-4469-b6d1-f318f6adfd262024-07-12WarningsName fallback
generic name: ALCOHOL
Ecolab FaciliproALCOHOLEcolab Inc.87aa66da-bbc7-4d02-851b-63c19e68578a2024-07-12WarningsName fallback
generic name: ALCOHOL
Assorted Licensed Hand Sanitizer Grape 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.1c9095ad-ce19-3666-e063-6394a90ae22d2024-07-09WarningsName fallback
generic name: ALCOHOL
Sani Luxe Hand Sanitizer with AlcoholALCOHOLCeleste Industries Corporation1a259dcf-4d82-4a42-be1f-0e557e0940bd2024-07-08WarningsName fallback
generic name: ALCOHOL
Sani LuxeALCOHOLCeleste Industries Corporationba0f4e72-c50a-41c0-e053-2995a90aeee12024-07-08WarningsName fallback
generic name: ALCOHOL
Assorted Licensed Hand Sanitizer Sweet pea 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.1cc8a756-852f-6cf8-e063-6394a90a57e62024-07-08WarningsName fallback
generic name: ALCOHOL

Reported adverse events (FAERS/openFDA)#

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