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 63 of 82 · 1,638 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Germ Attack Hand SanitizerALCOHOLNatural Essentials, Inc.9d3a4dfe-f31d-4def-bfc2-ece69d13f8e42024-10-04WarningsName fallback
generic name: ALCOHOL
PurellALCOHOLNavajo Manufacturing Company Inc.969b2968-8497-4125-949a-6be39b132edb2024-10-02WarningsName fallback
generic name: ALCOHOL
MY MEDIC SUPER SANITIZERALCOHOLNantong Health & Beyond Hygienic Products Inc.f19971b1-2aeb-4c37-82b0-9525026cff7a2024-10-02WarningsName fallback
generic name: ALCOHOL
GenRx Anti-Bacterial GelALCOHOLPureTek Corporationa124e37e-1a44-212a-e053-2995a90a0af02024-10-01WarningsName fallback
generic name: ALCOHOL
Hand Sanitizing with Lavender OilALCOHOLPureTek Corporationa75d25a7-1e23-717f-e053-2a95a90a6d932024-10-01WarningsName fallback
generic name: ALCOHOL
AOSI HEALTHCARE HAND SANITIZERALCOHOLNantong Health & Beyond Hygienic Products Inc.59d631d0-d8ae-45a8-a7a9-26de9cc427b32024-09-25WarningsName fallback
generic name: ALCOHOL
Danielle Creations Hand Sanitizer - StrawberryALCOHOLGanzhou Olivee Cosmetic Co., Ltd.7c4bab88-af65-48c2-8440-3ba7b139c0132024-09-10WarningsName fallback
generic name: ALCOHOL
Danielle Creations Hand Sanitizer - AppleALCOHOLGanzhou Olivee Cosmetic Co., Ltd.362d3233-79ac-41d8-9991-b5fc75c6cae92024-09-10WarningsName fallback
generic name: ALCOHOL
Danielle Creations Hand Sanitizer - PeachALCOHOLGanzhou Olivee Cosmetic Co., Ltd.ad28fe19-2b81-40c2-8ffb-f9b09c79def82024-09-10WarningsName fallback
generic name: ALCOHOL
Sani-SureALCOHOLWhisk Products, Inc.215090ce-5f54-35e7-e063-6394a90ae6552024-09-04WarningsName fallback
generic name: ALCOHOL
BERRIS AND CREAMY SCENTED HAND SANITIZERALCOHOLGanzhou Olivee Cosmetic Co., Ltd.30fc7f33-238c-42a3-93a1-72b98d303d9a2024-08-28WarningsName fallback
generic name: ALCOHOL
MANGO SORBET SCENTED HAND SANITIZERALCOHOLGanzhou Olivee Cosmetic Co., Ltd.d44e43e1-717d-47a1-a152-45f12288cbd22024-08-28WarningsName fallback
generic name: ALCOHOL
COCONUT VANILLA SCENTED HAND SANITIZERALCOHOLGanzhou Olivee Cosmetic Co., Ltd.574324ee-d98b-4939-889c-21ed04a4e46d2024-08-28WarningsName fallback
generic name: ALCOHOL
STRAWBERRY SHORTCAKE SCENTED HAND SANITIZERALCOHOLGanzhou Olivee Cosmetic Co., Ltd.997d0ff0-96b4-4b91-87fc-8f67d9b5013c2024-08-28WarningsName fallback
generic name: ALCOHOL
hand sanitizer 01ALCOHOLCosmuses Cosmetics (Ningbo) Co., Ltd.202dfeac-6e69-8667-e063-6294a90a26d22024-08-21WarningsName fallback
generic name: ALCOHOL
antibacterial hand sanitizer gel 01ALCOHOLCosmuses Cosmetics (Ningbo) Co., Ltd.202e5c15-8749-0a76-e063-6294a90a27202024-08-21WarningsName fallback
generic name: ALCOHOL
PDI Sani-Hands Instant Hand Sanitizing WipesALCOHOLProfessional Disposables International, Inc.3a5d6c74-6bd1-4494-9eda-5c6297c9b1e02024-08-21WarningsName fallback
generic name: ALCOHOL
PDI Sani-Hands Instant Hand Sanitizing WipesALCOHOLProfessional Disposables International, Inc.d43b7f97-4ecb-4b81-a975-c02f516dcaef2024-08-20WarningsName fallback
generic name: ALCOHOL
Sani Professional Hands Instant Sanitizing WipesALCOHOLProfessional Disposables International, Inc.96d92653-2b7d-6fd0-e053-2995a90ae04d2024-08-20WarningsName fallback
generic name: ALCOHOL
DermaCen Lotionized Hand SanitizerALCOHOLCentral Solutions Inc1f1e6c95-533f-d3e4-e063-6394a90a05602024-08-07WarningsName fallback
generic name: ALCOHOL

Reported adverse events (FAERS/openFDA)#

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