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 12 of 83 · 1,660 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Anti Bacterial Hand Gel Fresh WatermelonALCOHOLBath & Body Works, Inc.552fed13-f329-27bc-e063-6294a90ae1312026-06-26WarningsName fallback
generic name: ALCOHOL
Anti Bacterial Hand Gel Neapolitan Ice CreamALCOHOLBath & Body Works, Inc.552ff8dc-b38a-0c47-e063-6394a90a47c32026-06-26WarningsName fallback
generic name: ALCOHOL
Anti Bacterial Hand Gel Pink Peach BlossomALCOHOLBath & Body Works, Inc.552fe6d9-3364-0842-e063-6394a90a98452026-06-26WarningsName fallback
generic name: ALCOHOL
Iced Lemon Pound Cake Pistachio Milk and HoneyALCOHOLBath & Body Works, Inc.552fe73b-38dc-0c49-e063-6394a90a64742026-06-26WarningsName fallback
generic name: ALCOHOL
Anti Bacterial Hand Gel Cozy Vanilla AlmondALCOHOLBath & Body Works, Inc.55300198-e9c1-4539-e063-6294a90a90f12026-06-26WarningsName fallback
generic name: ALCOHOL
Anti Bacterial Hand Gel Pina Colada SwirlALCOHOLBath & Body Works, Inc.552ffde3-ccce-2ffd-e063-6394a90a08402026-06-26WarningsName fallback
generic name: ALCOHOL
Anti Bacterial Hand Gel Ghoul FriendALCOHOLBath & Body Works, Inc.55300198-e9bc-4539-e063-6294a90a90f12026-06-26WarningsName fallback
generic name: ALCOHOL
Anti Bacterial Hand Gel Sweet Tea and LemonadeALCOHOLBath & Body Works, Inc.552ffc4e-aded-ff0e-e063-6294a90abdc02026-06-26WarningsName fallback
generic name: ALCOHOL
Anti Bacterial Hand Gel Wildberry French ToastALCOHOLBath & Body Works, Inc.552ff81f-28da-0f6e-e063-6394a90ab5832026-06-26WarningsName fallback
generic name: ALCOHOL
Anti Bacterial Hand Gel Cotton Candy CobwebsALCOHOLBath & Body Works, Inc.5530026f-04cf-471f-e063-6294a90a165e2026-06-26WarningsName fallback
generic name: ALCOHOL
Anti Bacterial Hand Gel Endless WeekendALCOHOLBath & Body Works, Inc.552fe73b-38e1-0c49-e063-6394a90a64742026-06-26WarningsName fallback
generic name: ALCOHOL
Anti Bacterial Hand Gel Vampire BloodALCOHOLBath & Body Works, Inc.55300198-e9be-4539-e063-6294a90a90f12026-06-26WarningsName fallback
generic name: ALCOHOL
Smart Care Hand Sanitizers 2pk Apple and MarshmallowALCOHOLShenzhen Lantern Scicence Co.,Ltd.54e6b242-6f50-0e3e-e063-6294a90a52692026-06-23WarningsName fallback
generic name: ALCOHOL
Meijer Hand Sanitizer Silicone Holiday Gift Set 3pkALCOHOLShenzhen Lantern Scicence Co.,Ltd.54e6ecb7-5cd5-fc13-e063-6294a90a038c2026-06-23WarningsName fallback
generic name: ALCOHOL
Family Beauty Hydrating Hand Sanitizer, Aloe ScentedALCOHOLFamily Dollar Stores, LLC394c35ad-90b1-476c-84b9-2dbf973444532026-06-23WarningsName fallback
generic name: ALCOHOL
Smart Care Hand Sanitizers 2pk Cherry Blossom and French VanillaALCOHOLShenzhen Lantern Scicence Co.,Ltd.54e431cd-98fb-8346-e063-6294a90ad85e2026-06-22WarningsName fallback
generic name: ALCOHOL
Smart Care Holiday Hand Sanitizer-GingerbreadALCOHOLShenzhen Lantern Scicence Co.,Ltd.54cea78b-515c-9562-e063-6394a90af1b42026-06-21WarningsName fallback
generic name: ALCOHOL
Smart Care Holiday Hand Sanitizer-MistletoeALCOHOLShenzhen Lantern Scicence Co.,Ltd.54cecbb4-5d85-dacf-e063-6294a90af8072026-06-21WarningsName fallback
generic name: ALCOHOL
Smart Care Silicone Case for Hand Sanitizer BarbieALCOHOLShenzhen Lantern Scicence Co.,Ltd.54cef14d-dd2b-905f-e063-6294a90a66ba2026-06-21WarningsName fallback
generic name: ALCOHOL
Smart Care Silicone Case for Hand Sanitizer MermicornoALCOHOLShenzhen Lantern Scicence Co.,Ltd.54cedd57-03a9-e5e5-e063-6394a90a486b2026-06-21WarningsName fallback
generic name: ALCOHOL

Reported adverse events (FAERS/openFDA)#

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