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 74 of 82 · 1,638 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Antibacterial Hand SanitizerALCOHOLZhejiang Ayan Biotech Co.,Ltd.9c563e53-2246-cd57-e053-2995a90a82d72023-11-06WarningsName fallback
generic name: ALCOHOL
Antibacterial Hand SanitizerALCOHOLZhejiang Ayan Biotech Co.,Ltd.9c5753a4-f8af-9f09-e053-2995a90ad1382023-11-06WarningsName fallback
generic name: ALCOHOL
Hand SanitizerALCOHOLZhejiang Ayan Biotech Co.,Ltd.a29c47b9-1a99-5272-e053-2a95a90af4f62023-11-06WarningsName fallback
generic name: ALCOHOL
Hand SanitizerALCOHOLZhejiang Ayan Biotech Co.,Ltd.50ac080f-ae60-49dd-a01f-7b9bd8ea73a82023-11-06WarningsName fallback
generic name: ALCOHOL
Antibacterial Hand SanitizerALCOHOLProstock LLCa185a4b0-a5d3-2487-e053-2995a90a01d32023-11-06WarningsName fallback
generic name: ALCOHOL
Antibacterial Hand SanitizerALCOHOLProstock LLC1f4833c5-fcac-4c01-a5c6-e72837ca0a482023-11-06WarningsName fallback
generic name: ALCOHOL
Antibacterial Hand SanitizerALCOHOLProstock LLCa185c9c8-aabe-0e63-e053-2995a90a1b1e2023-11-06WarningsName fallback
generic name: ALCOHOL
Antibacterial Hand SanitizerALCOHOLProstock LLCce2d6c41-9423-45bd-8cbf-6749fdbb2c9f2023-11-06WarningsName fallback
generic name: ALCOHOL
Hand SanitizerALCOHOLProstock LLC9e7d7912-d594-47e9-bd8a-cc4f8ac85b2c2023-11-06WarningsName fallback
generic name: ALCOHOL
Hand SanitizerALCOHOLDegasa, S.A. de C.V.c93048f4-8c26-44c0-a966-7ef8662a7b312023-11-05WarningsName fallback
generic name: ALCOHOL
Protec Hand Sani Gel AntibacterialALCOHOLDegasa, S.A. de C.V.78f0fcd0-96eb-4432-8e2a-da4c6d70cf9a2023-11-05WarningsName fallback
generic name: ALCOHOL
Degasa Hand Sanitizer Lemon Lime ScentALCOHOLDegasa, S.A. de C.V.004bfacb-f79a-4f8a-9c8d-1d6e0dde1ce52023-11-05WarningsName fallback
generic name: ALCOHOL
Iso-Quin hand sanitizerALCOHOLThe Hygenic Company, LLC.d1003c9f-a6f8-3de2-e053-2995a90a6e8a2023-11-05WarningsName fallback
generic name: ALCOHOL
Hand SanitizerALCOHOLDegasa, S.A. de C.V.6ccffef3-99c6-4663-b9d7-9f50216eb13f2023-11-05WarningsName fallback
generic name: ALCOHOL
AMBI Soothing Hand sanitizerALCOHOLAMBI Enterprises, llc229a2afd-9f33-42b9-916d-df1e787181f72023-11-05WarningsName fallback
generic name: ALCOHOL
Justice Cucumber And Melon Scented Anti-bacterial Hand SanitizerALCOHOLTween Brands, Inc.7823d0de-880e-4c56-acc7-b5c03dbf0e7a2023-11-03WarningsName fallback
generic name: ALCOHOL
Hand SanitizerALCOHOLTravel Retail Global Inc.62ec5bf1-9467-4c9b-b83d-6709f2146e0a2023-10-31WarningsName fallback
generic name: ALCOHOL
CleanGenic Foaming Hand SanitizerALCOHOLCleanGenic, LLCb9829141-8222-3381-e053-2995a90ac0332023-10-28WarningsName fallback
generic name: ALCOHOL
CleanGenic 1 GALLON HAND SANITIZERALCOHOLCleanGenic, LLCb982987b-c462-1ade-e053-2995a90ae6f72023-10-28WarningsName fallback
generic name: ALCOHOL
Foaming Alcohol Hand SanitizerALCOHOLSimoniz USA, Incd8925e9b-dd6e-4fad-aa3f-ae8fb895f2e12023-10-28WarningsName fallback
generic name: ALCOHOL

Reported adverse events (FAERS/openFDA)#

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