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 22 of 83 · 1,660 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Anti-BacterialHandSpray Marshmallow Pumpkin Latte ALCOHOL Bath & Body Works, Inc. 463d408a-be41-2e5e-e063-6394a90a9ee6 2026-03-10 Warnings Name fallback generic name: ALCOHOL Anti Bacterial Hand Gel Winter Candy Apple ALCOHOL Bath & Body Works, Inc. 4513447b-b36e-d2b6-e063-6394a90ae4f9 2026-03-10 Warnings Name fallback generic name: ALCOHOL Anti Bacterial Hand Gel Champagne Apple and Honey ALCOHOL Bath & Body Works, Inc. 4650ac33-8d90-a5e7-e063-6294a90a18ed 2026-03-10 Warnings Name fallback generic name: ALCOHOL Anti Bacterial Moisturizing Hand Sanitizer Lavender Bergamot ALCOHOL Bath & Body Works, Inc. 463d04c8-4df0-d3e5-e063-6394a90a0ff2 2026-03-10 Warnings Name fallback generic name: ALCOHOL Anti Bacterial Hand Gel Touch of Gold ALCOHOL Bath & Body Works, Inc. 4650bdad-a4ad-cb5e-e063-6394a90ab240 2026-03-10 Warnings Name fallback generic name: ALCOHOL Anti Bacterial Hand Gel Fresh Balsam ALCOHOL Bath & Body Works, Inc. 468c94df-7cf9-780f-e063-6294a90aa50f 2026-03-10 Warnings Name fallback generic name: ALCOHOL Anti Bacterial Moisturizing Hand Sanitizer Beautiful Day ALCOHOL Bath & Body Works, Inc. 463cb528-a54a-fc36-e063-6294a90a903d 2026-03-10 Warnings Name fallback generic name: ALCOHOL Anti-BacterialHandSpray Gingerbread Bakery ALCOHOL Bath & Body Works, Inc. 463f0966-c7a7-2bcb-e063-6394a90a2611 2026-03-10 Warnings Name fallback generic name: ALCOHOL Anti-BacterialHandSpray Pineapple Mango ALCOHOL Bath & Body Works, Inc. 463fc682-c8e4-17c7-e063-6294a90a21e6 2026-03-10 Warnings Name fallback generic name: ALCOHOL Anti Bacterial Hand Gel Japanese Cherry Blossom ALCOHOL Bath & Body Works, Inc. 468c8e7a-95bb-6ad0-e063-6294a90a7ce9 2026-03-10 Warnings Name fallback generic name: ALCOHOL Anti-BacterialHandSpray Blackberries and Basil ALCOHOL Bath & Body Works, Inc. 463d31cc-a5b9-19cf-e063-6394a90af6af 2026-03-10 Warnings Name fallback generic name: ALCOHOL Anti-BacterialHandSpray Bright Christmas Morning ALCOHOL Bath & Body Works, Inc. 463eeded-9977-abac-e063-6294a90a4a74 2026-03-10 Warnings Name fallback generic name: ALCOHOL Anti Bacterial Hand Gel Book Loft ALCOHOL Bath & Body Works, Inc. 4650ab55-8ce6-a5e1-e063-6294a90a79bf 2026-03-10 Warnings Name fallback generic name: ALCOHOL Anti Bacterial Hand Gel Pure Wonder ALCOHOL Bath & Body Works, Inc. 468c90d7-3b9c-1641-e063-6394a90a928c 2026-03-10 Warnings Name fallback generic name: ALCOHOL Anti-BacterialHandSpray Tree Farm ALCOHOL Bath & Body Works, Inc. 463f1c97-cbbe-4735-e063-6394a90a3b5a 2026-03-10 Warnings Name fallback generic name: ALCOHOL Anti-BacterialHandSpray Cucumber Melon ALCOHOL Bath & Body Works, Inc. 463fa1ef-d40c-d818-e063-6294a90a5e61 2026-03-10 Warnings Name fallback generic name: ALCOHOL Anti-BacterialHandSpray Twisted Peppermint ALCOHOL Bath & Body Works, Inc. 463f5b3a-d693-869c-e063-6394a90ac8d0 2026-03-10 Warnings Name fallback generic name: ALCOHOL Anti-BacterialHandSpray Spring Apple ALCOHOL Bath & Body Works, Inc. 463fcad3-0c5c-599f-e063-6394a90a8d21 2026-03-10 Warnings Name fallback generic name: ALCOHOL Anti Bacterial Hand Gel Pink Peach Blossom ALCOHOL Bath & Body Works, Inc. 4650bac0-c64a-f595-e063-6294a90abdf2 2026-03-10 Warnings Name fallback generic name: ALCOHOL Anti Bacterial Moisturizing Hand Sanitizer Gingerbread Bakery ALCOHOL Bath & Body Works, Inc. 4690a48e-b80e-cafc-e063-6394a90aa6a1 2026-03-10 Warnings Name fallback generic name: ALCOHOL
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.