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 51 of 83 · 1,660 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Meijer Hydrating Hand Sanitizer 1oz - BerryALCOHOLShenzhen Lantern Scicence Co.,Ltd.322c56b0-7eb6-c33a-e063-6394a90a15fb2025-04-07WarningsName fallback
generic name: ALCOHOL
Meijer Hydrating Hand Sanitizer 1oz - VanillaALCOHOLShenzhen Lantern Scicence Co.,Ltd.322ce179-c528-0f62-e063-6394a90ac5602025-04-07WarningsName fallback
generic name: ALCOHOL
ETHYL ALCOHOLALCOHOLASP Global LLC67a4b949-ce8a-4841-a965-fcc94165135c2025-04-02WarningsName fallback
generic name: ALCOHOL
Beautifier Life Hand Sanitizer Mist OceanALCOHOLShenzhen Lantern Scicence Co.,Ltd.31628598-f7b8-111b-e063-6394a90a3de22025-03-28WarningsName fallback
generic name: ALCOHOL
Beautifier Life Hand Sanitizer Mist WatermelonALCOHOLShenzhen Lantern Scicence Co.,Ltd.31633195-d964-278b-e063-6294a90ad42d2025-03-28WarningsName fallback
generic name: ALCOHOL
Beautifier Life Hand Sanitizer Mist CucumberALCOHOLShenzhen Lantern Scicence Co.,Ltd.31642cc2-c3f6-891d-e063-6294a90a28582025-03-28WarningsName fallback
generic name: ALCOHOL
Symmetry Foaming Hand SanitizerALCOHOLBuckeye International, Inc.1cfcad5c-3896-3f69-e063-6294a90a8d9e2025-03-27WarningsName fallback
generic name: ALCOHOL
Altra Foaming Hand Sanitizer Fragrance Free with Aloe and Vitamin EALCOHOLBuckeye International, Inc.1cfe0fba-69a0-6eb8-e063-6294a90a05822025-03-27WarningsName fallback
generic name: ALCOHOL
Symmetry Foaming Hand Sanitizer Fragrance FreeALCOHOLBuckeye International, Inc.1ce8bcc4-9b1a-1464-e063-6294a90a1e9e2025-03-27WarningsName fallback
generic name: ALCOHOL
health beyond HAND SANITIZERALCOHOLNantong Health & Beyond Hygienic Products Inc.e5746be7-e9dc-42a6-a3d0-b386427caec52025-03-27WarningsName fallback
generic name: ALCOHOL
Symmetry Foaming Hand Sanitizer-Fragrance Free with Aloe and Vitamin EALCOHOLBuckeye International, Inc.00a2c2b4-b540-4acc-86b9-b4dfb4e8695b2025-03-25Warnings, Adverse reactionsName fallback
generic name: ALCOHOL
Altra Foaming Hand Sanitizer with Aloe and Vitamin EALCOHOLBuckeye International, Inc.a28ff21e-a507-8257-e053-2a95a90afd4e2025-03-25WarningsName fallback
generic name: ALCOHOL
Altra Foaming Hand Sanitizer Fragrance Free with Aloe and Vitamin EALCOHOLBuckeye International, Inc.a2963c01-55f7-a3cc-e053-2a95a90a72c62025-03-25WarningsName fallback
generic name: ALCOHOL
Smart Care Hand Sanitizer 3pk 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.30997964-e81e-2159-e063-6294a90ad5dc2025-03-18WarningsName fallback
generic name: ALCOHOL
Smart Care Hand Sanitizer 3pk 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.309abafa-0118-dd48-e063-6294a90a6e9f2025-03-18WarningsName fallback
generic name: ALCOHOL
B Pure Moisturizing Hand Sanitizer Poppy ScentedALCOHOLFourstar Group USA, Incd466ebf3-6642-44dc-a9e9-f528bc45d7a02025-03-18WarningsName fallback
generic name: ALCOHOL
B Pure Moisturizing Hand Sanitizer Rainbow Sherbert ScentedALCOHOLFourstar Group USA, Ince09a6def-0adc-4e51-97d9-4f3d6d96bbdd2025-03-18WarningsName fallback
generic name: ALCOHOL
Smart Care Strawberry Hand Sanitizer strawberry 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.3086faf2-e6e3-a7da-e063-6394a90ace542025-03-17WarningsName fallback
generic name: ALCOHOL
Alcare OR Foaming Antiseptic HandrubALCOHOLSC Johnson Professional USA Incb3a54ee6-fe64-4b48-8208-7bd586dfd0892025-03-14WarningsName fallback
generic name: ALCOHOL
Signature Care Instant Hand Sanitizizer WipesALCOHOLYiwu Yangjie Daily Chemicals Co.,Ltd.0f6a30de-4100-4673-ab9e-256bb137919b2025-03-11WarningsName fallback
generic name: ALCOHOL

Reported adverse events (FAERS/openFDA)#

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