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 32 of 83 · 1,660 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Smart Care Hand Sanitizer Jasmine JewelALCOHOLShenzhen Lantern Scicence Co.,Ltd.49e891ac-fa83-f687-e063-6294a90a52552026-02-03WarningsName fallback
generic name: ALCOHOL
Smart Care Hand Sanitizer RosebudALCOHOLShenzhen Lantern Scicence Co.,Ltd.49e8bca0-e872-2585-e063-6294a90a34b22026-02-03WarningsName fallback
generic name: ALCOHOL
Hand SanitizerALCOHOLCVS Pharmacy, Inc.3ea2f838-3ad8-4913-8736-9da82f5cef4b2026-02-03Warnings, Adverse reactionsName fallback
generic name: ALCOHOL
Latalia Alcohol Antiseptic 80% SanitizingALCOHOLINTERNATIONAL CONSUMER PRODUCTS (PVT) LTD2da50235-5d89-4774-9c92-bb22cee081f12026-02-03WarningsName fallback
generic name: ALCOHOL
Hand SanitizerALCOHOLDemoulas Super Markets, Incbfe6c08a-a584-4bfb-b28f-492333a0082a2026-02-03Warnings, Adverse reactionsName fallback
generic name: ALCOHOL
Smart Care Hand Sanitizer Morning DewALCOHOLShenzhen Lantern Scicence Co.,Ltd.49f60996-6a03-77e0-e063-6394a90a7a112026-02-03WarningsName fallback
generic name: ALCOHOL
Smart Care Hand Sanitizer Wild Cherry BlossomALCOHOLShenzhen Lantern Scicence Co.,Ltd.49f64148-5c63-0107-e063-6294a90a0c452026-02-03WarningsName fallback
generic name: ALCOHOL
Smart Care Hand Sanitizer Citrus SunsetALCOHOLShenzhen Lantern Scicence Co.,Ltd.49f67a60-a6d8-0aa4-e063-6394a90a98592026-02-03WarningsName fallback
generic name: ALCOHOL
B Pure Moisturizing Hand Sanitizer Watermelon ScentedALCOHOLFourstar Group USA, Incc97eae06-df1f-4f3e-bef3-66882a3898932026-02-02WarningsName fallback
generic name: ALCOHOL
B Pure Moisturizing Hand Sanitizer Cucumber Mint ScentedALCOHOLFourstar Group USA, Inc26ae8950-a770-4755-aa51-7e3a24cdae842026-02-02WarningsName fallback
generic name: ALCOHOL
Advanced Hand SanitizerALCOHOLRite Aid Corporationf7eb3c0e-4e53-45d8-88f9-95026f5e3efb2026-01-30Warnings, Adverse reactionsName fallback
generic name: ALCOHOL
AlcoholALCOHOLAldi, Incaaa55815-ab6d-41c0-b04f-53de8001ebc72026-01-29WarningsName fallback
generic name: ALCOHOL
Adventure Hand Sanitizer - Fragrance 80%ALCOHOLNICETY SOLUTIONS LLCa507c20e-37d8-ea80-e053-2a95a90a41d42026-01-29WarningsName fallback
generic name: ALCOHOL
Adventure Hand Sanitizer - Unscented 80%ALCOHOLNICETY SOLUTIONS LLCa5077eb2-4adb-0680-e053-2995a90a2cef2026-01-29WarningsName fallback
generic name: ALCOHOL
ESC Protecting Foam Hand SanitizerALCOHOLEcolab Inc.d0820c4c-b320-4d3d-8ee3-de24fbed227b2026-01-29WarningsName fallback
generic name: ALCOHOL
Singular Wipes fresh Citrus ScentALCOHOLSINGULAR ENTERPRISES LLC867a25d2-3d2c-4dad-bbe8-84195c03a87d2026-01-27WarningsName fallback
generic name: ALCOHOL
Signature Select Instant Hand Sanitizer Wipes with Aloe VeraALCOHOLLiving Better Brands LLCcf4b671f-697a-47d3-921e-2de4330739182026-01-26WarningsName fallback
generic name: ALCOHOL
Signature Select Advanced Hand Sanitizer with Aloe VeraALCOHOLLiving Better Brands LLCcbf0fead-0729-460b-82c0-1596c995cf2b2026-01-26WarningsName fallback
generic name: ALCOHOL
Signature Select Advanced Hand SanitizerALCOHOLLiving Better Brands LLC6d1cc25b-d612-4aae-bdb0-304758ef8f0f2026-01-26WarningsName fallback
generic name: ALCOHOL
Juniper Clean Hand SanitizerALCOHOLKYNC Design LLCa6bb7f88-ac9b-4f72-e053-2995a90ac15c2026-01-23WarningsName fallback
generic name: ALCOHOL

Reported adverse events (FAERS/openFDA)#

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