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 70 of 82 · 1,638 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AntimicrobialALCOHOLSafetec of America, Inc.4a070d45-f7fd-4eab-a2ba-48445d54fe5d2024-02-05WarningsName fallback
generic name: ALCOHOL
Antibacterial Hand SanitizerALCOHOLTEKWELD SOLUTIONS, INC.45af86a4-a413-0309-e054-00144ff88e882024-02-05WarningsName fallback
generic name: ALCOHOL
Instant Hand SanitizerALCOHOLSafetec of America, Inc.6d8677fa-8d7e-4eb5-9f20-ec5a84e1c23f2024-02-04WarningsName fallback
generic name: ALCOHOL
Merci Handy Sanctuary Hand Sanitizer ZODIAC SETALCOHOLMERCI HANDY CORPORATIONbfcd01f3-4a7b-263a-e053-2a95a90aa1d42024-01-23WarningsName fallback
generic name: ALCOHOL
Holiday Dust SetALCOHOLMERCI HANDY CORPORATIONa3bea733-8957-472f-9761-57a431d3759a2024-01-23WarningsName fallback
generic name: ALCOHOL
Upside Down Collector Fanny PackALCOHOLMERCI HANDY CORPORATIONc71ad08a-a6ea-db30-e053-2995a90a4cef2024-01-23WarningsName fallback
generic name: ALCOHOL
Upside Down Set Vol 1 HandcareALCOHOLMERCI HANDY CORPORATIONc71ad0ea-921b-be5b-e053-2995a90acc252024-01-23WarningsName fallback
generic name: ALCOHOL
Upside Down Set Vol 2 BodycareALCOHOLMERCI HANDY CORPORATIONc71ac5c2-d90e-eb62-e053-2a95a90a76932024-01-23WarningsName fallback
generic name: ALCOHOL
Hand SanitizerALCOHOLCustom Chemical Solutionsa7c07167-b27b-8217-e053-2995a90ac5412024-01-22WarningsName fallback
generic name: ALCOHOL
HAND SANITIZERALCOHOLCustom Chemicial Solutionsb10420a9-b290-4536-e053-2a95a90a99972024-01-22WarningsName fallback
generic name: ALCOHOL
Hand Sanitizer FoamALCOHOLCustom Chemical Solutionsb0f1cb6f-0b47-7652-e053-2a95a90a7c6b2024-01-22WarningsName fallback
generic name: ALCOHOL
Medical SuperALCOHOLBeijing HKKY Medical Tech. Co., Ltd.ed2649c6-d971-4338-8745-cd0a40f7b0c22024-01-13WarningsName fallback
generic name: ALCOHOL
Antibacterial Hand SanitizerALCOHOLTEKWELD INCf8dcfaed-9b3d-4c7a-a93e-407c7f62051f2024-01-12WarningsName fallback
generic name: ALCOHOL
Mirador Health Foaming Alcohol Hand SanitizerALCOHOLBest Sanitizers, Inc.0eaf12ac-e558-0d2d-e063-6294a90ad9e72024-01-11WarningsName fallback
generic name: ALCOHOL
ER Hand Sanitizer PacketsALCOHOLEVER READY FIRST AIDd0b6d09c-26e0-45c7-8d37-7d42143b2e312024-01-11WarningsName fallback
generic name: ALCOHOL
Latalia Hand Sanitizer 80 Alcohol AntisepticALCOHOLINTERNATIONAL CONSUMER PRODUCTS (PVT.) LTDae55fab3-3177-383e-e053-2995a90a17a02024-01-10WarningsName fallback
generic name: ALCOHOL
Latalia Sanitizing WipeALCOHOLINTERNATIONAL CONSUMER PRODUCTS (PVT.) LTDae564635-898e-fbf6-e053-2995a90a81192024-01-10WarningsName fallback
generic name: ALCOHOL
Latalia Sanitizing WipesALCOHOLINTERNATIONAL CONSUMER PRODUCTS (PVT) LTDaf850b5e-c99f-3d4e-e053-2995a90a79482024-01-10WarningsName fallback
generic name: ALCOHOL
Latalia Alcohol Antiseptic 80 SanitizingALCOHOLINTERNATIONAL CONSUMER PRODUCTS (PVT) LTDba4b8fb3-09db-fa29-e053-2995a90a86172024-01-10WarningsName fallback
generic name: ALCOHOL
Northside Hospital Amenity Kit--GI DeptALCOHOLASP Global, LLcc284eba4-0b92-4981-b3f8-d8d99b58bdfd2024-01-10WarningsName fallback
generic name: ALCOHOL

Reported adverse events (FAERS/openFDA)#

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