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 76 of 82 · 1,638 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PARASOL SCENT-FREE HAND SANITIZERALCOHOLWe've Got Chemistry LLC84a9b4da-9b95-41cf-8453-876f79650e292023-10-26WarningsName fallback
generic name: ALCOHOL
Hand Sanitizer Alcohol HandALCOHOLDesign International Group095af1a8-6966-4807-8724-84fec8d8045f2023-10-26WarningsName fallback
generic name: ALCOHOL
BUBBLE GUM HAND SANITIZER boyALCOHOLK7 Design Group Inc.a4e669d2-5482-7c20-e053-2995a90ab0502023-10-26WarningsName fallback
generic name: ALCOHOL
citrus crush scent hand sanitizer robotALCOHOLK7 DESIGN GROUP INC4753fd57-9868-4b02-aa8b-618241e1a9832023-10-26WarningsName fallback
generic name: ALCOHOL
FINEAPPLE Hand SanitizerALCOHOLCROP BEAUTY GROUP INC.316625c6-dd73-485c-a617-ed86ebf2ac022023-10-26WarningsName fallback
generic name: ALCOHOL
lemon lime scent hand sanitizerALCOHOLK7 DESIGN GROUP INC92415631-e00b-471d-9bca-5851777bcaa82023-10-26WarningsName fallback
generic name: ALCOHOL
MELON DOLLAR Hand SanitizerALCOHOLCROP BEAUTY GROUP INC.32a974cd-3b2c-4120-b48f-31651ad7bc1a2023-10-26WarningsName fallback
generic name: ALCOHOL
choco mallow melt hand sanitizerALCOHOLTarget Corporationeb483c27-ba83-4899-ae63-933467eec2862023-10-26WarningsName fallback
generic name: ALCOHOL
Hand SanitizerALCOHOLBOZZANO Group948881d0-1740-47bd-9a49-d18e9e5532472023-10-26WarningsName fallback
generic name: ALCOHOL
berry blitz hand sanitizerALCOHOLTarget Corporation2436a562-b7bb-4ff5-9f9f-fb98b3490c662023-10-26WarningsName fallback
generic name: ALCOHOL
ANTI BACTERIAL HAND SANITIZERALCOHOLMiWorld Accesories LLCc107373c-6ff6-407c-ac38-17cfdd72b72b2023-10-26WarningsName fallback
generic name: ALCOHOL
SFT1 Sanitizing WipesALCOHOLORR Safetyb787fa1d-1e15-245b-e053-2a95a90a00a12023-10-26WarningsName fallback
generic name: ALCOHOL
PEPPERMINT TWIST HAND SANITIZERALCOHOLTarget Corporation3203ebbd-413b-4579-bd1d-798008c588aa2023-10-26WarningsName fallback
generic name: ALCOHOL
COCONUT MACAROON HAND SANITIZERALCOHOLTarget Corporation2eb42750-fa10-47c3-8398-e1d5929528d52023-10-26WarningsName fallback
generic name: ALCOHOL
SUGARED LEMON HAND SANITIZERALCOHOLTarget Corporationd0ef9002-de9d-4d9b-91a6-cc2f0553c8632023-10-26WarningsName fallback
generic name: ALCOHOL
Hand SanitizerALCOHOLORR Safety Corporationb2e133f6-87f4-4a01-96af-8941190f558c2023-10-26WarningsName fallback
generic name: ALCOHOL
SPARKLING CRANBERRY HAND SANITIZERALCOHOLTarget Corporation7ca828e8-ff43-4e4c-8e8c-d760a0f0c2222023-10-26WarningsName fallback
generic name: ALCOHOL
Justice Glitter Berry Scented Anti-bacterial Hand Sanitizer LlamaALCOHOLTween Brands, Inc.6b6abc11-369d-4835-b420-8f3208ee4c422023-10-26WarningsName fallback
generic name: ALCOHOL
Hand SanitizerALCOHOLORR Safety Corporation59d944ce-b28b-491d-b158-334ed43ca4d42023-10-26WarningsName fallback
generic name: ALCOHOL
VANILLA SUGAR COOKIE HAND SANITIZERALCOHOLTarget Corporationedca9c75-ba4e-4229-8fe7-a153932f7ca12023-10-26WarningsName fallback
generic name: ALCOHOL

Reported adverse events (FAERS/openFDA)#

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