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 52 of 82 · 1,638 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Licensed Hand Sanitizer Spider man 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.2e16c9bc-223d-0c65-e063-6294a90a48152025-02-14WarningsName fallback
generic name: ALCOHOL
Hand Sanitizer 2pk Lemon 2ozALCOHOLNingbo Rejoice Internationalb08ea7ef-a595-6bef-e053-2a95a90a68fb2025-02-13WarningsName fallback
generic name: ALCOHOL
Hand Sanitizer Original 8ozALCOHOLNingbo Rejoice Internationalb08ec92b-e63e-2dab-e053-2995a90a09482025-02-13WarningsName fallback
generic name: ALCOHOL
Hand Sanitizer with Clip 1.8ozALCOHOLNingbo Rejoice Internationalb08f2909-467d-719d-e053-2995a90a11a12025-02-13WarningsName fallback
generic name: ALCOHOL
Hand Sanitizer 2pk Aloe 2ozALCOHOLNingbo Rejoice Internationalb08f2993-f166-1a0e-e053-2a95a90a93792025-02-13WarningsName fallback
generic name: ALCOHOL
Hand Sanitizer Aloe 2ozALCOHOLNingbo Rejoice Internationalb08f3bf1-f55f-5c68-e053-2a95a90ac3ac2025-02-13WarningsName fallback
generic name: ALCOHOL
Hand Sanitizer Lavender 2ozALCOHOLNingbo Rejoice Internationalb08f6f48-796b-3b40-e053-2a95a90a75f62025-02-13WarningsName fallback
generic name: ALCOHOL
Hand Sanitizer 2pk Lavender 2ozALCOHOLNingbo Rejoice Internationalb08f62b0-98dd-5aac-e053-2a95a90a6d8a2025-02-13WarningsName fallback
generic name: ALCOHOL
Hand Sanitizer PouchALCOHOLNingbo Rejoice Internationalb08f8faa-d9d6-5b8d-e053-2a95a90a407c2025-02-13WarningsName fallback
generic name: ALCOHOL
Hand Sanitizer 24ct PouchALCOHOLNingbo Rejoice Internationalb08fb47c-7241-45d3-e053-2a95a90a8a942025-02-13WarningsName fallback
generic name: ALCOHOL
Hand Sanitizer 2ozALCOHOLNingbo Rejoice Internationalb08fd11a-48e2-67b6-e053-2995a90ac3992025-02-13WarningsName fallback
generic name: ALCOHOL
Hand Sanitizer Aloe 8ozALCOHOLNingbo Rejoice Internationalb1914c86-4489-fbb8-e053-2995a90a5cd62025-02-13WarningsName fallback
generic name: ALCOHOL
Hand Sanitizer Coconut and Lime 3ozALCOHOLNingbo Rejoice Internationalbc07a905-b740-5e44-e053-2a95a90a4db92025-02-13WarningsName fallback
generic name: ALCOHOL
Hand Sanitizer Cucumber and Melon 3ozALCOHOLNingbo Rejoice Internationalbc0810e9-2381-4212-e053-2995a90a264e2025-02-13WarningsName fallback
generic name: ALCOHOL
Hand Sanitizer Pomegranate and Vanilla 3ozALCOHOLNingbo Rejoice Internationalbc082139-f868-2f20-e053-2995a90ab9462025-02-13WarningsName fallback
generic name: ALCOHOL
Smart Care Assorted Licensed Sanitizer Spider Man 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.2dedab76-3f5a-febf-e063-6394a90a69932025-02-12WarningsName fallback
generic name: ALCOHOL
Smart Care Assorted Licensed Sanitizer Barbie 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.2dfd2ffd-a85a-f63e-e063-6294a90a6a5e2025-02-12WarningsName fallback
generic name: ALCOHOL
Smart Care Assorted Licensed Sanitizer Crayola 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.2dfd4acb-451b-12d3-e063-6294a90a48732025-02-12WarningsName fallback
generic name: ALCOHOL
Smart Care Assorted Licensed Sanitizer Hot Wheels 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.2dfdd225-24f4-6d57-e063-6394a90a8a242025-02-12WarningsName fallback
generic name: ALCOHOL
Smart Care Cucumber Melon Hand Sanitizer 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.2dfe0ac7-99d5-aac3-e063-6294a90a31b32025-02-12WarningsName fallback
generic name: ALCOHOL

Reported adverse events (FAERS/openFDA)#

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