Home Applications 083483 Application 083483
Type ANDA
Sponsor MILES Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ALCOHOL 5% IN DEXTROSE 5% ALCOHOL INJECTABLE;INJECTION 5ML/100ML No No
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2019-12-13 00:20 UTC 2019-12 A083483-001 ALCOHOL 5% IN DEXTROSE 5% 5ML/100ML INJECTABLE / INJECTION Approved before 1982 74a2ff9319b5…2021-12-28 21:50 UTC 2021-12 A083483-001 ALCOHOL 5% IN DEXTROSE 5% 5ML/100ML INJECTABLE / INJECTION Approved before 1982 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A083483-001 ALCOHOL 5% IN DEXTROSE 5% 5ML/100ML INJECTABLE / INJECTION Approved before 1982 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A083483-001 ALCOHOL 5% IN DEXTROSE 5% 5ML/100ML INJECTABLE / INJECTION Approved before 1982 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A083483-001 ALCOHOL 5% IN DEXTROSE 5% 5ML/100ML INJECTABLE / INJECTION Approved before 1982 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A083483-001 ALCOHOL 5% IN DEXTROSE 5% 5ML/100ML INJECTABLE / INJECTION Approved before 1982 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A083483-001 ALCOHOL 5% IN DEXTROSE 5% 5ML/100ML INJECTABLE / INJECTION Approved before 1982 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A083483-001 ALCOHOL 5% IN DEXTROSE 5% 5ML/100ML INJECTABLE / INJECTION Approved before 1982 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A083483-001 ALCOHOL 5% IN DEXTROSE 5% 5ML/100ML INJECTABLE / INJECTION Approved before 1982 ea99ee380514…
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 11 of 83 · 1,660 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Anti Bacterial Hand Gel White Tea and Sage ALCOHOL Bath & Body Works, Inc. 552fed13-f320-27bc-e063-6294a90ae131 2026-06-26 Warnings Name fallback generic name: ALCOHOL Anti Bacterial Hand Gel Pink Peach Blossom ALCOHOL Bath & Body Works, Inc. 552feb22-c355-0572-e063-6394a90afa8c 2026-06-26 Warnings Name fallback generic name: ALCOHOL Anti Bacterial Hand Gel Sunshine and Lemons ALCOHOL Bath & Body Works, Inc. 552fccdd-93c4-efff-e063-6294a90a54ba 2026-06-26 Warnings Name fallback generic name: ALCOHOL Anti Bacterial Hand Gel Raspberry Tangerine ALCOHOL Bath & Body Works, Inc. 552fe6d9-335d-0842-e063-6394a90a9845 2026-06-26 Warnings Name fallback generic name: ALCOHOL Anti Bacterial Hand Gel Marine Waves and Citrus ALCOHOL Bath & Body Works, Inc. 552fe62e-5e18-1fed-e063-6294a90a489e 2026-06-26 Warnings Name fallback generic name: ALCOHOL Anti Bacterial Hand Gel Watermelon Lemonade ALCOHOL Bath & Body Works, Inc. 552fe6d9-335f-0842-e063-6394a90a9845 2026-06-26 Warnings Name fallback generic name: ALCOHOL Anti Bacterial Hand Gel Turquoise Waters ALCOHOL Bath & Body Works, Inc. 552fe62e-5e1e-1fed-e063-6294a90a489e 2026-06-26 Warnings Name fallback generic name: ALCOHOL Anti Bacterial Hand Gel Eucalyptus Rain ALCOHOL Bath & Body Works, Inc. 552ff8dc-b386-0c47-e063-6394a90a47c3 2026-06-26 Warnings Name fallback generic name: ALCOHOL Anti Bacterial Hand Gel Waikiki Beach Coconut ALCOHOL Bath & Body Works, Inc. 552fe62e-5e1d-1fed-e063-6294a90a489e 2026-06-26 Warnings Name fallback generic name: ALCOHOL Anti Bacterial Hand Gel Pink Pineapple Sunrise ALCOHOL Bath & Body Works, Inc. 552fed13-f326-27bc-e063-6294a90ae131 2026-06-26 Warnings Name fallback generic name: ALCOHOL Anti Bacterial Moisturizing Hand Sanitizer Coconut Pina Colada ALCOHOL Bath & Body Works, Inc. 552fe733-25f7-30a7-e063-6294a90a4464 2026-06-26 Warnings Name fallback generic name: ALCOHOL Anti Bacterial Hand Gel Fresh Rainfall ALCOHOL Bath & Body Works, Inc. 552fed13-f323-27bc-e063-6294a90ae131 2026-06-26 Warnings Name fallback generic name: ALCOHOL Anti Bacterial Hand Gel Firecracker Pop ALCOHOL Bath & Body Works, Inc. 552ff8dc-b388-0c47-e063-6394a90a47c3 2026-06-26 Warnings Name fallback generic name: ALCOHOL Anti Bacterial Hand Gel Japanese Cherry Blossom ALCOHOL Bath & Body Works, Inc. 552fe733-25f9-30a7-e063-6294a90a4464 2026-06-26 Warnings Name fallback generic name: ALCOHOL Anti Bacterial Hand Gel Pineapple Mango ALCOHOL Bath & Body Works, Inc. 552fe733-25fc-30a7-e063-6294a90a4464 2026-06-26 Warnings Name fallback generic name: ALCOHOL Anti Bacterial Hand Gel Peach Blossom and Nectar ALCOHOL Bath & Body Works, Inc. 552feb22-c34c-0572-e063-6394a90afa8c 2026-06-26 Warnings Name fallback generic name: ALCOHOL Anti Bacterial Hand Gel Butterfly ALCOHOL Bath & Body Works, Inc. 552ff81f-28d9-0f6e-e063-6394a90ab583 2026-06-26 Warnings Name fallback generic name: ALCOHOL Anti Bacterial Hand Gel Strawberry Kiwi ALCOHOL Bath & Body Works, Inc. 552fe584-b74d-00ad-e063-6394a90a68e7 2026-06-26 Warnings Name fallback generic name: ALCOHOL Anti Bacterial Hand Gel Fresh Cut Lilacs ALCOHOL Bath & Body Works, Inc. 552feb22-c353-0572-e063-6394a90afa8c 2026-06-26 Warnings Name fallback generic name: ALCOHOL Anti Bacterial Hand Gel Pink Kiwi Berry ALCOHOL Bath & Body Works, Inc. 552ff8dc-b387-0c47-e063-6394a90a47c3 2026-06-26 Warnings Name fallback generic name: ALCOHOL
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.