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 4 of 83 · 1,660 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dehydrated AlcoholALCOHOLBreckenridge Pharmaceutical Incbe10b253-d72a-4f57-aa27-94c70ae8aed32026-08-27Warnings, Adverse reactionsName fallback
generic name: ALCOHOL
Surface x Cutie Pals Hand Sanitizer SurpriseALCOHOLI WORLD, LLC2e274b4a-953e-47ce-aa73-81576a4677102026-08-27WarningsName fallback
generic name: ALCOHOL
Surface x Cutie Pals Hand Sanitizer Cherry PieALCOHOLI WORLD, LLC771fdce8-c633-4592-9bbf-5985c2536f2d2026-08-27WarningsName fallback
generic name: ALCOHOL
Smart Care Hand Sanitizer,2pk with Woven Lanyard and Charms - Sparkling Watermelon/ Pomegranate RaspberryALCOHOLShenzhen Lantern Scicence Co.,Ltd.5a2a89f4-838e-e3ea-e063-6294a90a1ac22026-08-27WarningsName fallback
generic name: ALCOHOL
InstantFoam Complete PUREALCOHOLSC Johnson Professional USA Inc.398ca23c-7202-4670-be14-9829675f71742026-08-27WarningsName fallback
generic name: ALCOHOL
Be Smart Get Prepared Hand SanitizerALCOHOLTotal Resources International, Inc23d0dc62-28d6-4d1f-a7d5-4b14f5c9fb1e2026-08-24WarningsName fallback
generic name: ALCOHOL
hand sanitizer- light blue 01ALCOHOLCosmuses Cosmetics (Ningbo) Co., Ltd.598a96f0-33fe-40aa-e063-6394a90aeacb2026-08-21WarningsName fallback
generic name: ALCOHOL
hand sanitizer- light green 01ALCOHOLCosmuses Cosmetics (Ningbo) Co., Ltd.598a165a-90ff-e00c-e063-6394a90a33512026-08-21WarningsName fallback
generic name: ALCOHOL
hand sanitizer- light purple 01ALCOHOLCosmuses Cosmetics (Ningbo) Co., Ltd.598b7bb8-0d2e-a66f-e063-6294a90a45b82026-08-21WarningsName fallback
generic name: ALCOHOL
hand sanitizer- light yellow 01ALCOHOLCosmuses Cosmetics (Ningbo) Co., Ltd.598bf8cd-2a79-8b56-e063-6394a90a42a82026-08-21WarningsName fallback
generic name: ALCOHOL
hand sanitizer- light pink 01ALCOHOLCosmuses Cosmetics (Ningbo) Co., Ltd.598c41f0-908d-df52-e063-6394a90a3c8d2026-08-21WarningsName fallback
generic name: ALCOHOL
AlcoholALCOHOLLidl US, LLCc7746330-2943-491a-bafc-0c8dd4fa40e22026-08-18Warnings, Adverse reactionsName fallback
generic name: ALCOHOL
AlcoholALCOHOLNice-Pak Products, LLCdc071394-60de-4b13-a962-9a643b01b1062026-08-18Warnings, Adverse reactionsName fallback
generic name: ALCOHOL
Zep Fuzion Instant Hand SanitizerALCOHOLZep Inc.b43c5701-22ee-1de4-e053-2995a90a8f642026-08-13WarningsName fallback
generic name: ALCOHOL
Zep Instant Hand Sanitizer GelALCOHOLZep Inc.b0ee8023-0128-56d6-e053-2a95a90ab4ed2026-08-13WarningsName fallback
generic name: ALCOHOL
Zep Instant Hand Sanitizer GelALCOHOLZep Inc.b0ed98cd-871b-d862-e053-2995a90a14cc2026-08-13WarningsName fallback
generic name: ALCOHOL
SprinJeneALCOHOLHealth and Natural Beauty USA Corp1853f023-f4db-4cd8-a4df-a439bc306cc32026-08-13WarningsName fallback
generic name: ALCOHOL
WhiskCare 373ALCOHOLWhisk Products, Inc.57d5cd5d-8597-ce66-e063-6394a90a00472026-08-12WarningsName fallback
generic name: ALCOHOL
ZoviroALCOHOLZoviro, LLC9c8ca084-8aef-4616-8d51-aaff3eb253432026-08-12WarningsName fallback
generic name: ALCOHOL
Aire-Master Foaming Hand Sanitizer Fragrance FreeALCOHOLWhisk Products, Inc.56a8f08e-7683-d155-e063-6394a90ac77b2026-08-11WarningsName fallback
generic name: ALCOHOL

Reported adverse events (FAERS/openFDA)#

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