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 62 of 82 · 1,638 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Genuine First Aid Antiseptic Hand Sanitizer Ethyl AlcoholALCOHOLGFA Production (Xiamen) Co., Ltd.af08c1f3-b1c4-58aa-e053-2a95a90ab3202024-10-15WarningsName fallback
generic name: ALCOHOL
Genuine First Aid Hand Sanitizer Ethyl AlcoholALCOHOLGFA Production (Xiamen) Co., Ltd.af8466d7-794a-cb95-e053-2a95a90a6ffc2024-10-15WarningsName fallback
generic name: ALCOHOL
Genuine First Aid Hand Sanitizer with Cap Ethyl AlcoholALCOHOLGFA Production (Xiamen) Co., Ltd.af84bd67-4986-30e6-e053-2a95a90a8d932024-10-15WarningsName fallback
generic name: ALCOHOL
Genuine First Aid Hand Sanitizer with Pump Ethyl AlcoholALCOHOLGFA Production (Xiamen) Co., Ltd.af84b665-260a-596f-e053-2995a90ac38c2024-10-15WarningsName fallback
generic name: ALCOHOL
Genuine First Aid Hand Sanitizer Ethyl AlcoholALCOHOLGFA Production (Xiamen) Co., Ltd.af84bd67-4988-30e6-e053-2a95a90a8d932024-10-15WarningsName fallback
generic name: ALCOHOL
HILL COUNTRY FARE HAND SANITIZER WITH ALOE FRAGRANCEALCOHOLH.E.Bc89b48e9-1746-874b-e053-2995a90ab0712024-10-15WarningsName fallback
generic name: ALCOHOL
HEB Citrus Hand SanitizerALCOHOLH.E.B.c8ab20e5-6a20-5a6b-e053-2a95a90a247c2024-10-15WarningsName fallback
generic name: ALCOHOL
Antiseptic Hand SanitizerALCOHOLHubei Changjian Medical Products Co., Ltd.b7f00c15-852f-45ce-9c60-70e0b80234f52024-10-11WarningsName fallback
generic name: ALCOHOL
Alcohol Disinfecting WipeALCOHOLMcKesson Medical-Surgical64a0063d-a5da-4a46-9dca-16e4dbdac85c2024-10-11WarningsName fallback
generic name: ALCOHOL
MistALCOHOLDerma Glove2a0bcc4e-5114-4afc-91cb-cb4816a63db22024-10-09WarningsName fallback
generic name: ALCOHOL
MistALCOHOLDerma Gloveb5bfd7f0-0f96-459e-84d4-24b2081ae46f2024-10-09WarningsName fallback
generic name: ALCOHOL
Hand RecoveryALCOHOLDerma Glove06f74478-57aa-4b8d-b888-55e1ee4fbd452024-10-09WarningsName fallback
generic name: ALCOHOL
MistALCOHOLDerma Glove7c21ee1c-ce2a-464b-8269-cdb3e59db0942024-10-09WarningsName fallback
generic name: ALCOHOL
MistALCOHOLDerma Glove11c2939c-e77a-48f6-949c-9d508714012b2024-10-09WarningsName fallback
generic name: ALCOHOL
Hand RecoveryALCOHOLDerma Glovee6cfe092-cb2c-441b-8897-98626c43bef82024-10-09WarningsName fallback
generic name: ALCOHOL
Hand RecoveryALCOHOLDerma Gloveb4ff67d6-27d6-4d31-a708-9c2e8d4f0f3e2024-10-09WarningsName fallback
generic name: ALCOHOL
MistALCOHOLDerma Glovedd849fb3-95af-4a32-9687-3b966d456fbb2024-10-09WarningsName fallback
generic name: ALCOHOL
Hand RecoveryALCOHOLDerma Gloved8705086-7209-4f13-bd54-604c90495f0a2024-10-09WarningsName fallback
generic name: ALCOHOL
FOAMING HAND ALCOHOL FOAMALCOHOLDraco Hygienic Products Inc.14860a19-e1e8-71fc-e063-6394a90a9df82024-10-08WarningsName fallback
generic name: ALCOHOL
Germ Attack Hand SanitizerALCOHOLNatural Essentials, Inc.4d156264-566d-4516-876c-b6f5823a97f52024-10-04WarningsName fallback
generic name: ALCOHOL

Reported adverse events (FAERS/openFDA)#

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