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 60 of 82 · 1,638 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ALPET E3 PLUS HAND SANITIZERALCOHOLBest Sanitizers, Inc.d6d64945-4cd4-4926-9ef9-898cea89e8112024-12-05WarningsName fallback
generic name: ALCOHOL
SMART SAN HAND SANITIZERALCOHOLBest Sanitizers, Inc.1c018851-82e0-4f2c-8f40-31674cd6fe2b2024-12-05WarningsName fallback
generic name: ALCOHOL
ALPET E3 HAND SANITIZER FOAMALCOHOLBest Sanitizers, Inc.53573e1a-a3f8-4598-8248-ec4a62392d002024-12-05WarningsName fallback
generic name: ALCOHOL
SMART SAN HAND SANITIZER FRAGRANCE-FREEALCOHOLBest Sanitizers, Inc.bce412dc-21db-4c63-b4fc-33538cda74242024-12-05WarningsName fallback
generic name: ALCOHOL
SMART SAN HAND SANITIZERALCOHOLBest Sanitizers, Inc.8a2cc051-604c-43a7-9f65-2f929b759daa2024-12-05WarningsName fallback
generic name: ALCOHOL
alcohol pad 01ALCOHOLCosmuses Cosmetics (Ningbo) Co., Ltd.03a6e8d4-535d-b316-e063-6294a90aebf52024-12-04WarningsName fallback
generic name: ALCOHOL
Watermelon Hand Sanitizer Spray. 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.1f0f9885-2ad5-09de-e063-6394a90ad0d72024-12-03WarningsName fallback
generic name: ALCOHOL
Antibacterial Hand SanitizerALCOHOLTEKWELD SOLUTIONS, INC.45afc52b-9838-1729-e054-00144ff8d46c2024-12-03WarningsName fallback
generic name: ALCOHOL
PURELL Advanced Hand Sanitizer Calming LavenderALCOHOLGOJO Industries, Inc.72244148-ad7e-47cf-96ff-48fc7f25d67d2024-12-03WarningsName fallback
generic name: ALCOHOL
Instant Hand AntisepticALCOHOLASP Global291eaa18-81f8-6907-e054-00144ff88e882024-12-03WarningsName fallback
generic name: ALCOHOL
Anti Bacterial Hand Gel Vanilla NoirALCOHOLBath & Body Works, Inc.284ee56f-36e1-c5f9-e063-6294a90a62512024-12-02WarningsName fallback
generic name: ALCOHOL
Servo Stat-FoamALCOHOLEnzyme Solutions, Inc.a4535b70-04cb-4227-81d3-4dd55086ba7a2024-11-26WarningsName fallback
generic name: ALCOHOL
Servo-StatALCOHOLEnzyme Solutions, Inc.70562cae-b316-4033-b457-40ba71f6881c2024-11-26WarningsName fallback
generic name: ALCOHOL
First Aid Only Instant Hand SanitizerALCOHOLAcme United Corporationc94e8db3-2db7-fce4-e053-2a95a90a62d92024-11-26WarningsName fallback
generic name: ALCOHOL
Instant Antiseptic Hand SanitizerALCOHOLUnited Laboratories Inc.f91a5ac5-0f78-4cf5-be57-6562714791cd2024-11-25WarningsName fallback
generic name: ALCOHOL
Harbor Mist Alco-Foam Hand SanitizerALCOHOLVon Drehle Corporationbfdefc20-494e-6156-e053-2995a90a77cb2024-11-25WarningsName fallback
generic name: ALCOHOL
Dynarex GreenALCOHOLDynarex Corporation072572be-49dd-4594-bc40-b56db57ada5b2024-11-20WarningsName fallback
generic name: ALCOHOL
Mada 70% AlcoholALCOHOLMada Medical Products, Inc.3b2c8181-9e14-4470-9c39-8f08c3e042ab2024-11-20WarningsName fallback
generic name: ALCOHOL
MadaALCOHOLMada Medical Products, Inc.b6d9d394-f660-490c-b3b3-d9e04f3681152024-11-20WarningsName fallback
generic name: ALCOHOL
b pure Hand Sanitizer Green Apple ScentedALCOHOLFourstar Group USA, Inc.fa166e4a-3b56-4b9e-89da-6a7b48d365252024-11-20WarningsName fallback
generic name: ALCOHOL

Reported adverse events (FAERS/openFDA)#

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