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 39 of 83 · 1,660 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CareALL Hand SanitizerALCOHOLNew World Imports, Inc.025a42bb-37e0-4d74-8f94-8a9ef2296f4c2025-12-01WarningsName fallback
generic name: ALCOHOL
EO Hand Sanitizer Wipes LavenderALCOHOLEO Products, LLCb66895a9-17eb-4493-aa9d-7ef4b2b0194a2025-11-27WarningsName fallback
generic name: ALCOHOL
everyone Hand Sanitizer Coconut LemonALCOHOLEO Products, LLC16528009-90cf-46b8-9719-bdc6f435a1912025-11-27WarningsName fallback
generic name: ALCOHOL
Everyone Hand Sanitizer ruby grapefruitALCOHOLEO Products, LLC045151b3-f08c-4e02-be33-00271e15b7f02025-11-27WarningsName fallback
generic name: ALCOHOL
Antibacterial Hand Sanitizer Spray.ALCOHOLHAIAN KANGRUI TEXTILE CO., LTD.3c242e55-4585-9f07-e063-6294a90a6fb42025-11-25WarningsName fallback
generic name: ALCOHOL
ORANGE HAND SANITIZER aloe and vitamin EALCOHOLGanzhou Olivee Cosmetic Co., Ltd.a9c1e4f6-e354-4624-a902-8c9154ea47232025-11-25WarningsName fallback
generic name: ALCOHOL
COCONUT HAND SANITIZER aloe and vitamin EALCOHOLGanzhou Olivee Cosmetic Co., Ltd.40d7fb84-4b39-440d-a590-8aaf8ec312d72025-11-25WarningsName fallback
generic name: ALCOHOL
Lerna Antiseptic Sanitizing Hand GelALCOHOLLernapharm Loris Inc.444f3c7e-8403-1385-e063-6294a90a253b2025-11-23WarningsName fallback
generic name: ALCOHOL
Surface x Cutie Pals Hand Sanitizer Citrus CrushALCOHOLI World LLC51e77091-b6ab-45e7-9be5-fc3a3e894bbb2025-11-21WarningsName fallback
generic name: ALCOHOL
Surface x Cutie Pals Hand Sanitizer Cherry ColaALCOHOLI World LLC4420574a-bc9b-a5aa-e063-6394a90a577f2025-11-21WarningsName fallback
generic name: ALCOHOL
EO HAND SANITIZER LavenderALCOHOLEO Products, LLC36b26803-ed48-498f-bc0e-15473495a35a2025-11-21WarningsName fallback
generic name: ALCOHOL
EO HAND SANITIZER LavenderALCOHOLEO Products, LLC4192e27f-0034-4cd9-b9e0-27b52cb4b9702025-11-21WarningsName fallback
generic name: ALCOHOL
EO HAND SANITIZER UnscentedALCOHOLEO Products, LLC7c2bf597-65f1-44ad-9cfd-05cd7e9973c82025-11-20WarningsName fallback
generic name: ALCOHOL
X-TERILALCOHOLAqua Medica, S.A. de C.V.43fa3055-27fb-2aa7-e063-6394a90a5ee52025-11-20WarningsName fallback
generic name: ALCOHOL
X-TERILALCOHOLAqua Medica, S.A. de C.V.c348800d-2837-095b-e053-2995a90ad7fd2025-11-20WarningsName fallback
generic name: ALCOHOL
X-TERILALCOHOLAqua Medica, S.A. de C.V.c3486a75-bcda-5288-e053-2995a90acdad2025-11-20WarningsName fallback
generic name: ALCOHOL
Recens FoamALCOHOLCertus Medical, Inc.ea384dfc-c894-3124-e053-2a95a90a81c22025-11-20WarningsName fallback
generic name: ALCOHOL
Plus Brasept Alcocol GelALCOHOLNEWDROP NORTH AMERICA LLCf791c99c-5879-9ba2-e053-6394a90ad3c72025-11-20WarningsName fallback
generic name: ALCOHOL
Scent Theory Hand Sanitizer (Peach Peony, Dragonfruit Paradise, Coastal Fleur)ALCOHOLScent Theory Products LLC440f0a52-de0a-8f44-e063-6294a90a18b52025-11-20WarningsName fallback
generic name: ALCOHOL
Hand-AidALCOHOLABC Compounding Co., Inc.788d7584-bc33-49e8-90fd-767045ea29142025-11-19WarningsName fallback
generic name: ALCOHOL

Reported adverse events (FAERS/openFDA)#

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