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 78 of 82 · 1,638 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Justice Confetti Cupcake Scented Anti-bacterial Hand SanitizerALCOHOLTween Brands, Inc.6680d766-1e87-400d-bb1d-1569d62f5ea32023-10-26WarningsName fallback
generic name: ALCOHOL
Justice Rainbow Peach Mango Scented Anti-bacterial Hand SanitizerALCOHOLTween Brands, Inc.3243c78f-51a5-4654-bd3a-d66d122bd9b02023-10-26WarningsName fallback
generic name: ALCOHOL
lavender life hand sanitizerALCOHOLTarget Corporationdf0a3166-1658-490c-b3a8-c226040e52202023-10-26WarningsName fallback
generic name: ALCOHOL
WATERMELON MANGO SCENTED HAND SANITIZERALCOHOLTarget Brands,Inc.9bcc3acd-1ee2-bc57-e053-2a95a90ab1892023-10-26WarningsName fallback
generic name: ALCOHOL
rose rush hand sanitizerALCOHOLTarget Corporationed3a4bfd-8dae-4bad-a9be-9de782baf7642023-10-26WarningsName fallback
generic name: ALCOHOL
gumdrop glitz hand sanitizerALCOHOLTarget Corporationc1731db5-34ac-4773-a99b-ac4eae7ab4332023-10-26WarningsName fallback
generic name: ALCOHOL
blue raspberry radiance hand sanitizerALCOHOLTarget Corporationa3778db7-0a32-4f7f-96ea-8defb1b0aac52023-10-26WarningsName fallback
generic name: ALCOHOL
Justice Berry Scented Anti-bacterial Hand Sanitizer BFFALCOHOLTween Brands, Inc.00aad8bd-43ec-457c-b561-588323ba1b3b2023-10-26WarningsName fallback
generic name: ALCOHOL
sugar cookie cheer hand sanitizerALCOHOLTarget Corporationd8878864-fb60-4081-a0c5-2e3c787392832023-10-26WarningsName fallback
generic name: ALCOHOL
Justice Amazing Melon Scented Antibacterial Hand SanitizerALCOHOLTween Brands,Inc9bcb51ed-fc11-4793-e053-2a95a90a4e5a2023-10-26WarningsName fallback
generic name: ALCOHOL
Justice Berry Scented Anti-bacterial Hand SanitizerALCOHOLTween Brands, Inc.e0d987ea-37a0-435b-a1d5-62af339455852023-10-26WarningsName fallback
generic name: ALCOHOL
Justice Vanilla Sprinkles Scented Anti-bacterial Hand SanitizerALCOHOLTween Brands, Inc.d2b7ed2b-4e2a-4026-8e01-a561fadc20372023-10-26WarningsName fallback
generic name: ALCOHOL
Justice Flamingo Berry Scented Anti bacterial Hand SanitizerALCOHOLTween Brands,Inc.9bcc4dec-d20e-bd11-e053-2a95a90a30b32023-10-26WarningsName fallback
generic name: ALCOHOL
sweet stardust hand sanitizerALCOHOLTarget Corporation25732bef-432a-440f-94ae-bf2de52d6bb42023-10-26WarningsName fallback
generic name: ALCOHOL
Justice Sweet Pineapple Scented Anti bacterial Hand SanitizerALCOHOLTween Brands,Inc.9bcc4dec-d213-bd11-e053-2a95a90a30b32023-10-26WarningsName fallback
generic name: ALCOHOL
Justice Watermelon and Strawberry Scented Anti-bacterial Hand SanitizerALCOHOLTween Brands, Inc.0cc7f1c3-6d0b-4610-9232-55b33f8b5fa32023-10-26WarningsName fallback
generic name: ALCOHOL
lemon love hand sanitizerALCOHOLTarget Corporation4d5a1130-0a81-4d60-bc00-3f42db548a372023-10-26WarningsName fallback
generic name: ALCOHOL
HAND SANITIZERALCOHOLAndaz Group LLC5033fcad-fb65-45b8-a4ec-c7b2c9d117932023-10-26WarningsName fallback
generic name: ALCOHOL
Hand SanitizerALCOHOLBeSafe Industries LLC08022a98-f11a-45e6-b81f-f423444d09722023-10-26WarningsName fallback
generic name: ALCOHOL
NSI Sanitizing WipesALCOHOLNORTHERN SAFETY CO., INC.35b1f614-c710-437c-aee2-8ec966d1dc8d2023-10-26WarningsName fallback
generic name: ALCOHOL

Reported adverse events (FAERS/openFDA)#

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