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 65 of 82 · 1,638 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Assorted Licensed Hand Sanitizer Vanilla 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.1cc90b2f-450f-1deb-e063-6394a90a64802024-07-08WarningsName fallback
generic name: ALCOHOL
EOCENE Dr. HANITIZERALCOHOLMISOCOSa3fe59d1-01b3-4a2c-e053-2a95a90af2b22024-07-05WarningsName fallback
generic name: ALCOHOL
Antibacterial Hand SanitizerALCOHOLCosmuses Cosmetics (Ningbo) Co., Ltdf531053d-82e4-7613-e053-2995a90a349f2024-07-02WarningsName fallback
generic name: ALCOHOL
Antibacterial Hand SanitizerALCOHOLCosmuses Cosmetics (Ningbo) Co., Ltd1ae5c268-1834-4ac2-931e-bb7fd0088cd22024-07-02WarningsName fallback
generic name: ALCOHOL
B-Pure Hydrating Hand Sanitizer Cucumber Mint ScentedALCOHOLFourstar Group USA, Inc.0a228b06-0e1d-6c75-e063-6294a90a9a0e2024-07-02WarningsName fallback
generic name: ALCOHOL
B-Pure Hydrating Hand Sanitizer Watermelon ScentedALCOHOLFourstar Group USA, Inc.0a229252-6368-7d52-e063-6294a90a0bc72024-07-02WarningsName fallback
generic name: ALCOHOL
Be Smart Get Prepared Hand SanitizerALCOHOLTotal Resources International, Ince7930ec4-6920-4abb-adce-8cc4de44801d2024-07-02WarningsName fallback
generic name: ALCOHOL
b pure Hand Sanitizer Lemon ScentedALCOHOLFOURSTAR GROUP USA, INC.3fc74eff-46d6-45f5-bfa5-76a6a923cb942024-06-28WarningsName fallback
generic name: ALCOHOL
b pure Hand Sanitizer Watermelon ScentedALCOHOLFourstar Group USA, Inc.102d3955-be15-4c1c-b097-c566d675ab7c2024-06-28WarningsName fallback
generic name: ALCOHOL
b pure Hand Sanitizer Aloe ScentedALCOHOLFOURSTAR GROUP USA, INC.efd7a413-d29b-4b18-97bb-82746376e3df2024-06-25WarningsName fallback
generic name: ALCOHOL
b pure Hand Sanitizer Eucalyptus ScentedALCOHOLFOURSTAR GROUP USA, INCd154ca37-a28d-48fb-94c8-add632c82bdc2024-06-25WarningsName fallback
generic name: ALCOHOL
Anti Bacterial Moisturizing Hand Gel LeavesALCOHOLBath & Body Works, Inc.1ba7e3fe-d83c-db66-e063-6394a90a3b3a2024-06-25WarningsName fallback
generic name: ALCOHOL
b pure Hand Sanitizer Shea Butter ScentedALCOHOLFOURSTAR GROUP USA, INC.1eca1353-3422-4e78-96a5-dd4603c04aac2024-06-25WarningsName fallback
generic name: ALCOHOL
Anti Bacterial Hand Gel Raspberries and Whipped VanillaALCOHOLBath & Body Works, Inc.1bbaa102-f43e-a7e8-e063-6394a90a89e82024-06-25WarningsName fallback
generic name: ALCOHOL
Anti Bacterial Hand Gel Mahogany CoconutALCOHOLBath & Body Works, Inc.1bba9390-36ba-20e2-e063-6294a90a4b882024-06-25WarningsName fallback
generic name: ALCOHOL
Anti Bacterial Hand Gel Kitchen MandarinALCOHOLBath & Body Works, Inc.1bbaa157-5f45-1c6c-e063-6294a90a11152024-06-25WarningsName fallback
generic name: ALCOHOL
Anti Bacterial Hand Gel White Tea and SageALCOHOLBath & Body Works, Inc.1bba9834-3c87-f5af-e063-6394a90aa6bd2024-06-25WarningsName fallback
generic name: ALCOHOL
Anti Bacterial Hand Gel Palo Santo and SageALCOHOLBath & Body Works, Inc.1ba4242c-4427-02e9-e063-6394a90a7c082024-06-24WarningsName fallback
generic name: ALCOHOL
Anti Bacterial Hand Gel Pineapple MangoALCOHOLBath & Body Works, Inc.1ba44b0e-05bd-d7f3-e063-6294a90a6a0c2024-06-24WarningsName fallback
generic name: ALCOHOL
Anti Bacterial Hand Gel Passionfruit and Banana FlowerALCOHOLBath & Body Works, Inc.1ba427ce-1504-51ec-e063-6394a90a36742024-06-24WarningsName fallback
generic name: ALCOHOL

Reported adverse events (FAERS/openFDA)#

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