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 81 of 82 · 1,638 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
INSTANT FREE HAND SANITIZERALCOHOLTravel Retail Global Inca3ffa72b-b7d4-463a-a880-66081f16bd1a2023-10-26WarningsName fallback
generic name: ALCOHOL
Justice Berry Scented Anti-bacterial Hand SanitizerALCOHOLTween Brands, Inc.8a465ff2-5cb5-43bc-a9a7-d4e2162ac90d2023-10-25WarningsName fallback
generic name: ALCOHOL
Justice 198824 You Rock Antibacterial Cotton Candy Blueberry Hand SanitizerALCOHOLTween Brands,Inc.84c4fb4b-9f63-4414-b8f3-39f65212f22a2023-10-25WarningsName fallback
generic name: ALCOHOL
Hand SanitizerALCOHOLBath Concept Cosmetics (Dongguan) Co., Ltd065e083f-3c13-495d-8619-df45c5fce68b2023-10-25WarningsName fallback
generic name: ALCOHOL
Hand SanitizerALCOHOLIn Designs Global LLCa2dcedcd-e071-176e-e053-2a95a90a176b2023-10-25WarningsName fallback
generic name: ALCOHOL
Artnaturals Scent Free Hand SanitizerALCOHOLVirgin Scent Inca2dd4b1d-6a46-2109-e053-2995a90aea082023-10-25WarningsName fallback
generic name: ALCOHOL
Slight Scent Hand SanitizerALCOHOLSobe Promos LLCa2dd3912-9ecb-22bf-e053-2995a90a08c22023-10-25WarningsName fallback
generic name: ALCOHOL
Instant Hand SanitizerALCOHOLICARCOVER INC.7aae2f7a-39ce-434e-be0e-bccb04a828642023-10-25WarningsName fallback
generic name: ALCOHOL
Antiseptic Antibacterial Hand SanitizerALCOHOLVirus Protection Systems,LLCf7348acc-8c8c-45ff-b282-dfcfde8b0aee2023-10-25WarningsName fallback
generic name: ALCOHOL
Watermelon Hand Sanitizer GirlALCOHOLK7 Design Group Inc.97cc79c1-7469-49d6-ae31-cd5878cd2e6e2023-10-25WarningsName fallback
generic name: ALCOHOL
Lavender Hand Sanitizer GirlALCOHOLK7 Design Group Inc.f5332570-c81e-4858-8d46-02d8ff5218052023-10-25WarningsName fallback
generic name: ALCOHOL
PEPPERMINT HAND SANITIZER boyALCOHOLK7 Design Group Inc.94ac4174-532a-4944-aa49-67060787e6a12023-10-25WarningsName fallback
generic name: ALCOHOL
Peppermint Hand Sanitizer GirlALCOHOLK7 Design Group Inc.acd5e0b4-97e5-4a19-94dc-d4f931696d452023-10-25WarningsName fallback
generic name: ALCOHOL
cheerful choco orange hand sanitizerALCOHOLTarget Corporation7eea44b5-ee6b-448f-a0ae-5da73841f1422023-10-25WarningsName fallback
generic name: ALCOHOL
Lemonade Hand Sanitizer BoyALCOHOLK7 Design Group Inc.9e07eb49-ebeb-47cd-b86a-5f1618a3d3ef2023-10-25WarningsName fallback
generic name: ALCOHOL
candy cutie hand sanitizerALCOHOLTarget Corporation920d0dc5-2803-4a25-8f1f-86d7ff61c5682023-10-25WarningsName fallback
generic name: ALCOHOL
Cherry Hand Sanitizer BoyALCOHOLK7 Design Group Inc.86624b99-65c6-45c0-bbee-49ee56d823eb2023-10-25WarningsName fallback
generic name: ALCOHOL
creamy cappuccino hand sanitizerALCOHOLTarget Corporationccecdc9e-4a59-4a02-bd82-699af9ed5e972023-10-25WarningsName fallback
generic name: ALCOHOL
Hand SanitizerALCOHOLGordon Industriese4846d7b-767b-41dd-ab49-dfc3d851f3e62023-10-25WarningsName fallback
generic name: ALCOHOL
G and H Protect Hand SanitizerALCOHOLAccess Business Group LLCe00a87bd-899c-4595-9263-73bb62595a572023-10-23WarningsName fallback
generic name: ALCOHOL

Reported adverse events (FAERS/openFDA)#

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