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 37 of 83 · 1,660 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
B-Pure Moisturizing Hand Sanitizer Sugar Pistachio ScentedALCOHOLFourstar Group USA, Inc.b80c402e-ecef-42fe-8cf5-7aa26254a3fe2025-12-17WarningsName fallback
generic name: ALCOHOL
Dehydrated AlcoholALCOHOLSolupharm Pharmazeutische Erzeugnisse GmbH372d3eb5-78ee-414c-a146-4a19e22661842025-12-17Warnings, Adverse reactionsName fallback
generic name: ALCOHOL
Keystone Liquid Hand SanitizerALCOHOLEcolab Inc.1d808912-f1ad-4eed-a52d-6c6a363ddba22025-12-16WarningsName fallback
generic name: ALCOHOL
EcolabALCOHOLEcolab Inc.69962e54-2e1f-404a-b039-5ebf77cabd5f2025-12-16WarningsName fallback
generic name: ALCOHOL
B Pure Hand Sanitizer Tropical Burst ScentedALCOHOLFourstar Group USA, Inc.90c59897-ae56-4c5f-a0da-ced827e63eb02025-12-10WarningsName fallback
generic name: ALCOHOL
B-Pure Moisturizing Hand Sanitizer Blossom Dream Scented Limited EditionALCOHOLFourstar Group USA, Inc.86c8b44e-a03b-4e58-913c-74a064a42eae2025-12-10WarningsName fallback
generic name: ALCOHOL
B-Pure Moisturizing Hand Sanitizer Coconut Praline Scented Limited EditionALCOHOLFourstar Group USA, Inc.64ea1fcf-026b-4179-8a9d-219818e00e4a2025-12-10WarningsName fallback
generic name: ALCOHOL
B-Pure Moisturizing Hand Sanitizer Guava Nectar Scented Limited EditionALCOHOLFourstar Group USA, Inc.29c9ea5e-f525-4107-98c0-9697ba9106ac2025-12-10WarningsName fallback
generic name: ALCOHOL
B-Pure Moisturizing Hand Sanitizer Mystic Tide ScentedALCOHOLFourstar Group USA, Inc.3c8dc2a0-2ddf-49c8-b1be-53d291f1c8862025-12-10WarningsName fallback
generic name: ALCOHOL
B-Pure Moisturizing Hand Sanitizer Twilight Dance ScentedALCOHOLFourstar Group USA, Inc.c073a34c-f654-4882-8c6d-87425537e2472025-12-10WarningsName fallback
generic name: ALCOHOL
PURELL Advanced Hand Sanitizer Naturals GelALCOHOLGOJO Industries, Inc.b36013d2-96a6-4c40-ad05-8d9c0d9cdb1f2025-12-10WarningsName fallback
generic name: ALCOHOL
Advanced Gel Hand SanitizerALCOHOLEcolab Inc.c69b563d-ea9d-4ebc-b9ca-b84bd4e0de852025-12-10WarningsName fallback
generic name: ALCOHOL
EO Hand Sanitizer Wipes LavenderALCOHOLEO Products, LLC1a8cb031-5608-400f-b924-feb6bbd17fa12025-12-09WarningsName fallback
generic name: ALCOHOL
75% Alcohol DisinfectantALCOHOLZhejiang Meimi Technology Co., Ltd.acfdfa78-69e7-27dc-e053-2a95a90a85482025-12-06WarningsName fallback
generic name: ALCOHOL
75% Alcohol DisinfectantALCOHOLZhejiang Meimi Technology Co., Ltd.ad0cdcf1-7d8b-dcc9-e053-2995a90a4b4b2025-12-06WarningsName fallback
generic name: ALCOHOL
Mrs. Meyers Clean Day Hand Sanitizer Basil ScentALCOHOLThe Caldrea Companyd263d012-997c-4029-b771-e8f346da59882025-12-04WarningsName fallback
generic name: ALCOHOL
El Valle Decolorized IodineALCOHOLPharmadel LLCfd7a227b-536c-b3f7-e053-6394a90a41582025-12-04WarningsName fallback
generic name: ALCOHOL
B-Pure Moisturizing Hand Sanitizer with Collagen, Pink Kiwi Splash ScentedALCOHOLFourstar Group USA, Inc.f8b8b820-467b-49eb-8bec-16d39ba32e962025-12-04WarningsName fallback
generic name: ALCOHOL
B-Pure Moisturizing Hand Sanitizer with Hyaluronic Acid, Berries and Cream ScentedALCOHOLFourstar Group USA, Inc.9b646c4e-69e7-44c2-afa3-8267c25e62022025-12-04WarningsName fallback
generic name: ALCOHOL
B-Pure Hand Sanitizer Coconut Vanilla ScentedALCOHOLFourstar Group USA, Inc.08d9499c-486c-464b-9d81-ba325b95482e2025-12-04WarningsName fallback
generic name: ALCOHOL

Reported adverse events (FAERS/openFDA)#

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