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 75 of 82 · 1,638 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CleanGenic 8 OZ HAND SANITIZERALCOHOLCleanGenic, LLCb9828dd7-63a1-0bf4-e053-2a95a90a45692023-10-28WarningsName fallback
generic name: ALCOHOL
Simple Hygiene foaming hand Sanitizer 62ALCOHOLFULLER INDUSTRIES, INC64ceef51-78a6-4beb-a0aa-d4d5f9a0d84e2023-10-28WarningsName fallback
generic name: ALCOHOL
Simple Hygiene Hand SanitizerALCOHOLFULLER INDUSTRIES, INCf2a4bdd0-f78b-4a62-b2d3-bb78e57886002023-10-28WarningsName fallback
generic name: ALCOHOL
CleanGenic Foaming Hand SanitizerALCOHOLCleanGenic, LLCb982b2ed-6565-326a-e053-2a95a90a72d22023-10-28WarningsName fallback
generic name: ALCOHOL
Instant Sanitizing GelALCOHOLSORA KOZMETIK SANAYI TICARET ANONIM SIRKETIadc84467-6c70-0246-e053-2995a90ac4e72023-10-28WarningsName fallback
generic name: ALCOHOL
Hygienic Instant Hand Sanitizing WipesALCOHOLSORA KOZMETIK SANAYI TICARET ANONIM SIRKETIadc7d12d-f746-140a-e053-2a95a90a90b02023-10-28WarningsName fallback
generic name: ALCOHOL
Instant Hand Sanitizing GelALCOHOLSORA KOZMETIK SANAYI TICARET ANONIM SIRKETIadc83823-a3b0-41b7-e053-2995a90a0de82023-10-28WarningsName fallback
generic name: ALCOHOL
bubble gum scent hand sanitizerALCOHOLK7 DESIGN GROUP INCc280949b-fe20-4bad-b8f5-018a01340f752023-10-26WarningsName fallback
generic name: ALCOHOL
Hand SanitizerALCOHOLK7 Design Group Inc.a4e65bc9-3a84-142c-e053-2995a90ade6a2023-10-26WarningsName fallback
generic name: ALCOHOL
PARASOL HAND SANITIZERALCOHOLWe've Got Chemistry LLCd06d1487-85a3-4e06-8532-75b825a498d42023-10-26WarningsName fallback
generic name: ALCOHOL
citrus crush scent hand sanitizer pandaALCOHOLK7 DESIGN GROUP INC9fb73aef-3eb3-4c3e-81cb-1d56fcd95a0b2023-10-26WarningsName fallback
generic name: ALCOHOL
JUSTICE 194011 HEART IT ANTIBAC BLACKBERRY AND VANILLA SCENTED ANTI-BACTERIAL HAND SANITIZERALCOHOLTween Brands, Inc.7695037a-5dfa-43f3-afd5-aa79a7a9dd7e2023-10-26WarningsName fallback
generic name: ALCOHOL
Lavender ALOE HAND SANITIZERALCOHOLK7 Design Group Inc.a4e6affd-bff8-0f6f-e053-2995a90a90222023-10-26WarningsName fallback
generic name: ALCOHOL
Natural ALOE HAND SANITIZERALCOHOLK7 Design Group Inc.a4e6c24d-732f-3ff9-e053-2995a90ae1f32023-10-26WarningsName fallback
generic name: ALCOHOL
BEAUTANIQ BEAUTY HAND SANITIZERALCOHOLCROP BEAUTY GROUP INC.e410c167-01a2-4908-a9a7-d1c5bdfe8de42023-10-26WarningsName fallback
generic name: ALCOHOL
BUBBLE GUM HAND SANITIZER girlALCOHOLK7 Design Group Inc.a4e6bf00-b8c9-0a2f-e053-2995a90a53ab2023-10-26WarningsName fallback
generic name: ALCOHOL
vanilla frosting scent hand sanitizerALCOHOLK7 DESIGN GROUP INC5960a9fc-3263-4881-9724-0575c4be31922023-10-26WarningsName fallback
generic name: ALCOHOL
knDR SANITIZERALCOHOLCROP BEAUTY GROUP INC.97f125d7-9ee9-4a0e-99e8-798df7ebb0ff2023-10-26WarningsName fallback
generic name: ALCOHOL
Hibiscus ROSE HAND SANITIZERALCOHOLK7 Design Group Inc.a4e6c24d-731e-3ff9-e053-2995a90ae1f32023-10-26WarningsName fallback
generic name: ALCOHOL
berry blast scent hand sanitizerALCOHOLK7 DESIGN GROUP INCffcfecbd-217f-41c8-9536-22c956de80f02023-10-26WarningsName fallback
generic name: ALCOHOL

Reported adverse events (FAERS/openFDA)#

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