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 59 of 82 · 1,638 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Zytec Hand Sanitizer Wipes 80% w/w AlcoholALCOHOLEmpack Spraytech Inc.ab86fd0c-40cd-0bb6-e053-2a95a90a76e22024-12-12WarningsName fallback
generic name: ALCOHOL
Smart San Hand SanitizerALCOHOLBest Sanitizers, Inc.b76459d8-747b-86f9-e053-2a95a90ab6542024-12-12WarningsName fallback
generic name: ALCOHOL
PURELL Hand Sanitizing WipeALCOHOLGOJO Industries, Inc.e1ad4ebd-63bb-4a39-83b9-c806e10a600d2024-12-12WarningsName fallback
generic name: ALCOHOL
PURELL Cottony Soft Hand Sanitizing WipeALCOHOLGOJO Industries, Inc.fc19689f-4826-4adf-8292-ea002cc4ad052024-12-12WarningsName fallback
generic name: ALCOHOL
PURELL Advanced E3 Rated Instant Hand Sanitizer FoamALCOHOLGOJO Industries, Inc.1f78370b-132a-4759-8cbc-b5e093f90f8d2024-12-12WarningsName fallback
generic name: ALCOHOL
Anti Bacterial Hand Gel Sun-Ripened RaspberryALCOHOLBath & Body Works, Inc.28edbdd5-f542-8409-e063-6394a90afc582024-12-11WarningsName fallback
generic name: ALCOHOL
PURELL Healthcare Advanced Hand Sanitizer GelALCOHOLGOJO Industries, Inc.e3eef311-7515-46e8-8643-ead7905961842024-12-11WarningsName fallback
generic name: ALCOHOL
Purell Advanced Moisturizing 2in1ALCOHOLGOJO Industries, Inc.950002ed-f3a2-4ede-98fe-762ee9f018b92024-12-11WarningsName fallback
generic name: ALCOHOL
Optimize Thick Hand SanitizerALCOHOLMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inca35b9348-c35f-7ba9-e053-2995a90a4a302024-12-11WarningsName fallback
generic name: ALCOHOL
PURELL Healthcare Advanced Hand Sanitizer ULTRA NOURISHING FoamALCOHOLGOJO Industries, Inc.4fa85619-257f-4a19-a8f2-5a2e4b8097262024-12-11WarningsName fallback
generic name: ALCOHOL
CVS Hand SanitizerALCOHOLCVSb5faeb31-67c7-2000-e053-2995a90a14092024-12-10WarningsName fallback
generic name: ALCOHOL
CSI E3 Hand SanitizerALCOHOLCentral Solutions Incaa07bb62-ef07-99e4-e053-2995a90ae4a82024-12-09WarningsName fallback
generic name: ALCOHOL
DermaCen Instant Hand SanitizerALCOHOLCentral Solutions Inc36783d30-a222-40fe-a5ea-61a2842a34c92024-12-09WarningsName fallback
generic name: ALCOHOL
DermaCen Instant Hand Sanitizer with AloeALCOHOLCentral Solutions Incdc6191ae-841f-48b6-b454-72d8d43fdcce2024-12-09WarningsName fallback
generic name: ALCOHOL
DERMACEN FOAMING INSTANT HAND SANITIZER WITH ALOEALCOHOLCentral Solutions Incd56b9930-b8b0-ad72-e053-2a95a90af5902024-12-09WarningsName fallback
generic name: ALCOHOL
BLUESEA DISPOSABLE HAND SANITIZERALCOHOLBLUE SEA AEROSOL & DAILY CARE CO., LTD7a552be2-a9e1-4c6f-b1c2-79113a73bd2f2024-12-06WarningsName fallback
generic name: ALCOHOL
BLUESEA INSTANT HAND SANITIZERALCOHOLBLUE SEA AEROSOL & DAILY CARE CO., LTDe6b5ce49-d6d6-4b24-8b40-bfb1fb7005bd2024-12-06WarningsName fallback
generic name: ALCOHOL
Instant Hand AntisepticALCOHOLASP Globalb84075db-be0c-4265-b262-825bc6ade9d82024-12-06WarningsName fallback
generic name: ALCOHOL
Instant Hand AntisepticALCOHOLASP Global9aca3f89-cdde-430c-8eb6-43a3ac3fc0df2024-12-06WarningsName fallback
generic name: ALCOHOL
PURELL Advanced Hand Sanitizer Energizing MintALCOHOLGOJO Industries, Inc.a77f2ac3-2a8c-45e7-a65e-bd58e834249b2024-12-05WarningsName fallback
generic name: ALCOHOL

Reported adverse events (FAERS/openFDA)#

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