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 58 of 82 · 1,638 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PURELL VF PLUS Hand Sanitizer GelALCOHOLGOJO Industries, Inc.788a154e-f32f-410f-8648-f0bbd0772e662024-12-16WarningsName fallback
generic name: ALCOHOL
SAN X E3ALCOHOLAmerisan, LLCd6e219a6-f4d6-b8df-e053-2995a90a58032024-12-16WarningsName fallback
generic name: ALCOHOL
PURELL Advanced Hand Sanitizer Moisturizing 2in1 FoamALCOHOLGOJO Industries, Inc.19d4a358-74e0-4333-ace9-ed8b4ce729992024-12-16WarningsName fallback
generic name: ALCOHOL
PURELL Advanced Hand Sanitizer ULTRA NOURISHING FoamALCOHOLGOJO Industries, Inc.333246ca-9420-44c9-9240-37a9cdc03e2b2024-12-16WarningsName fallback
generic name: ALCOHOL
PURELL Advanced Hand Sanitizer Naturals FoamALCOHOLGOJO Industries, Inc.0b881323-938b-405f-beb2-0875256d37222024-12-16WarningsName fallback
generic name: ALCOHOL
PURELL Advanced Hand Sanitizer PRIME DEFENSEALCOHOLGOJO Industries, Inc.9962349e-ed78-4b22-be00-e38ab0c55dfe2024-12-16WarningsName fallback
generic name: ALCOHOL
PURELL Hand Sanitizer SP Lavender and VerbenaALCOHOLGOJO Industries, Inc.6a17d905-a55e-413c-b2af-0b06bf0d35c32024-12-16WarningsName fallback
generic name: ALCOHOL
PURELL Hand Sanitizer SP UnscentedALCOHOLGOJO Industries, Inc.f87058df-2efd-4ea8-ae37-35e472bd091f2024-12-16WarningsName fallback
generic name: ALCOHOL
PURELL Hand Sanitizer SP Tangerine and PearALCOHOLGOJO Industries, Inc.92df06a9-826b-493c-b865-295b8e9acb142024-12-16WarningsName fallback
generic name: ALCOHOL
PURELL Waterless Surgical ScrubALCOHOLGOJO Industries, Inc.e3ed5e0c-1e21-47eb-a999-9c8aa5083dff2024-12-16WarningsName fallback
generic name: ALCOHOL
Soft Care Impact Alcohol Instant Hand SanitizerALCOHOLDiversey, Inc.938d5a47-f18f-4bae-bd65-4fc98985e4282024-12-16WarningsName fallback
generic name: ALCOHOL
Soft Care Foam Instant Hand SanitizerALCOHOLDiversey, Inc.674e63ec-445b-4b7a-af15-63d9d624cf1a2024-12-16WarningsName fallback
generic name: ALCOHOL
Soft Care Impact Foam Alcohol Foam Instant Hand SanitizerALCOHOLDiversey, Inc.3b06c40c-9f15-4bc5-ad9b-053f4c4fc1b52024-12-16WarningsName fallback
generic name: ALCOHOL
Soft Care Hand Sanitizing WipesALCOHOLDiversey, Inc.97cd7474-05d7-30b8-e053-2995a90adf772024-12-16WarningsName fallback
generic name: ALCOHOL
Smart-San Hand Sanitizer FoamALCOHOLBest Sanitizers, Inc.291a53ff-b726-1acf-e063-6294a90a0aab2024-12-13WarningsName fallback
generic name: ALCOHOL
Anti Bacterial Hand Gel Sparkling LimoncelloALCOHOLBath & Body Works, Inc.292866b1-230b-771f-e063-6294a90ac3ef2024-12-13WarningsName fallback
generic name: ALCOHOL
Anti-BacterialHandSpray Champagne ToastALCOHOLBath & Body Works, Inc.2928bd10-05ca-fe75-e063-6294a90a01022024-12-13WarningsName fallback
generic name: ALCOHOL
Anti Bacterial Hand Gel Dazzling DiamondALCOHOLBath & Body Works, Inc.29291436-743c-c425-e063-6394a90a71652024-12-13WarningsName fallback
generic name: ALCOHOL
Alcare Enhanced Foaming Hand SanitizerALCOHOLSC Johnson Professional USA Inc.7180c18f-d436-4daf-9fec-7e73664228022024-12-13WarningsName fallback
generic name: ALCOHOL
Foaming Hand SanitizerALCOHOLEmpack Spraytech Inc.8bb072f2-9cd4-499d-9d7f-7166451b8f202024-12-12WarningsName fallback
generic name: ALCOHOL

Reported adverse events (FAERS/openFDA)#

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