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 61 of 82 · 1,638 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SUPER SENSITIVE HAND SANITIZERALCOHOLORGANIC & SUSTAINABLE BEAUTY7d4a5b21-82d2-4904-9577-4a9b2579076e2024-11-08WarningsName fallback
generic name: ALCOHOL
B-Pure Moisturizing Hand Sanitizer Ocean Breeze Scented with Hyaluronic AcidALCOHOLFOURSTAR GROUP USA, INC.ca9e9713-eae0-44aa-90df-09160f3812b52024-11-06WarningsName fallback
generic name: ALCOHOL
Hand SanitizerALCOHOLZhejiang Ayan Biotech Co.,Ltd.aec30cdb-6e95-4790-9c47-93202cc17dab2024-11-06WarningsName fallback
generic name: ALCOHOL
EUCALYPTUS EASE HAND SANITIZERALCOHOLORGANIC & SUSTAINABLE BEAUTY09d77591-9472-4771-9090-3390bddf788a2024-11-06WarningsName fallback
generic name: ALCOHOL
LEMON MYRTLE HAND SANITIZERALCOHOLORGANIC & SUSTAINABLE BEAUTYf341b24c-9466-42f4-98fe-d1a1225919152024-11-06WarningsName fallback
generic name: ALCOHOL
B-Pure Moisturizing Hand Sanitizer Passion Fruit Scented with CollagenALCOHOLFOURSTAR GROUP USA, INC.3523d797-8b5a-4c4c-838c-f743391c8a0d2024-11-05WarningsName fallback
generic name: ALCOHOL
CALMING HAND SANITIZERALCOHOLORGANIC & SUSTAINABLE BEAUTYffcbe34d-3c53-47f9-9e4a-b5448afbbd5d2024-11-05WarningsName fallback
generic name: ALCOHOL
B Pure Moisturizing Hand Sanitizer Coconut Lime ScentedALCOHOLFourstar Group USA, Inc2e4df751-1cbf-4128-9cb0-3d3abf394bae2024-11-01WarningsName fallback
generic name: ALCOHOL
B Pure Moisturizing Hand Sanitizer Hibiscus ScentedALCOHOLFourstar Group USA, Inc40cf9951-18c0-4abf-8467-d4b2f0a38adc2024-11-01WarningsName fallback
generic name: ALCOHOL
Lemongrass Hand SanitizerALCOHOLNatural Essentials, Inc.25ca3908-24aa-5e4f-e063-6394a90a7a882024-10-31WarningsName fallback
generic name: ALCOHOL
Lavender Hand SanitizerALCOHOLNatural Essentials, Inc.25cada8c-8c80-c140-e063-6294a90a33362024-10-31WarningsName fallback
generic name: ALCOHOL
Peppermint Hand SanitizerALCOHOLNatural Essentials, Inc.25cb382a-6e66-05e6-e063-6294a90a91652024-10-31WarningsName fallback
generic name: ALCOHOL
CVS HEALTH CONTINUOUS HAND SANITIZERALCOHOLCVS PHARMACYc89a28ac-ab53-46dd-e053-2a95a90a32842024-10-22WarningsName fallback
generic name: ALCOHOL
TRADER JOES HAND SANITIZER GRAPEFRUIT LEMONALCOHOLTrader Joe's Companyf4c1e80a-847b-4407-92b7-570c032bea602024-10-22WarningsName fallback
generic name: ALCOHOL
HAND SANITIZER RAINFALLALCOHOLSCENT THEORY PRODUCTS LLC24b1a25c-a3b6-9278-e063-6394a90a3ae22024-10-17WarningsName fallback
generic name: ALCOHOL
HAND SANITIZER RASPBERRY MANGOALCOHOLSCENT THEORY PRODUCTS LLC24b19489-4e59-0df8-e063-6394a90af6ae2024-10-17WarningsName fallback
generic name: ALCOHOL
HAND SANITIZER BRAZILIAN COCONUTALCOHOLSCENT THEORY PRODUCTS LLC24b1992a-d695-32b2-e063-6394a90a6cab2024-10-17WarningsName fallback
generic name: ALCOHOL
HAND SANITIZER LUSH ALOEALCOHOLSCENT THEORY PRODUCTS LLC24b1a25c-a3b8-9278-e063-6394a90a3ae22024-10-17WarningsName fallback
generic name: ALCOHOL
HAND SANITIZER SANDALWOOD WAVESALCOHOLSCENT THEORY PRODUCTS LLC24893800-464a-16ca-e063-6294a90a90652024-10-16WarningsName fallback
generic name: ALCOHOL
ProGel Max Hand SanitizerALCOHOLDelta Pharma Inc.a607897c-c398-1931-e053-2a95a90ae4832024-10-16WarningsName fallback
generic name: ALCOHOL

Reported adverse events (FAERS/openFDA)#

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