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 26 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 Pineapple Prosecco ALCOHOL Bath & Body Works, Inc. 38e1dc79-bdc5-3b84-e063-6294a90a61d7 2026-03-09 Warnings Name fallback generic name: ALCOHOL Anti Bacterial Hand Gel Eucalyptus Rain ALCOHOL Bath & Body Works, Inc. 38e1f158-187b-3b86-e063-6294a90a396f 2026-03-09 Warnings Name fallback generic name: ALCOHOL Anti Bacterial Hand Gel Ocean ALCOHOL Bath & Body Works, Inc. 38e1fd40-7a26-7fb1-e063-6394a90a5d06 2026-03-09 Warnings Name fallback generic name: ALCOHOL Anti Bacterial Hand Gel Lavender Bergamot ALCOHOL Bath & Body Works, Inc. 38e1d8fc-6f19-49d6-e063-6294a90a25ab 2026-03-09 Warnings Name fallback generic name: ALCOHOL Anti Bacterial Hand Gel Ghoul Friend ALCOHOL Bath & Body Works, Inc. 38e20376-982f-80b8-e063-6394a90ab5f8 2026-03-09 Warnings Name fallback generic name: ALCOHOL Anti Bacterial Hand Gel Candy Apple Cauldron ALCOHOL Bath & Body Works, Inc. 38e20b39-a44f-7fb3-e063-6394a90aec9f 2026-03-09 Warnings Name fallback generic name: ALCOHOL Anti Bacterial Hand Gel Vampire Blood ALCOHOL Bath & Body Works, Inc. 38e20dbe-817d-aa5e-e063-6394a90af008 2026-03-09 Warnings Name fallback generic name: ALCOHOL Anti Bacterial Hand Gel Disney Princess Tiana ALCOHOL Bath & Body Works, Inc. 38e21dcc-ea86-c6cd-e063-6294a90a057e 2026-03-09 Warnings Name fallback generic name: ALCOHOL Anti Bacterial Hand Gel Disney Princess Jasmine ALCOHOL Bath & Body Works, Inc. 38e22134-9664-bd86-e063-6294a90a6ae9 2026-03-09 Warnings Name fallback generic name: ALCOHOL Anti Bacterial Hand Gel Disney Princess Cinderella ALCOHOL Bath & Body Works, Inc. 38e20f82-19a5-7172-e063-6294a90a7eb3 2026-03-09 Warnings Name fallback generic name: ALCOHOL Anti Bacterial Hand Gel Disney Princess Moana ALCOHOL Bath & Body Works, Inc. 38e22134-9661-bd86-e063-6294a90a6ae9 2026-03-09 Warnings Name fallback generic name: ALCOHOL Anti Bacterial Hand Gel Disney Princess Belle ALCOHOL Bath & Body Works, Inc. 38e2212f-88d6-c792-e063-6394a90ae492 2026-03-09 Warnings Name fallback generic name: ALCOHOL Anti Bacterial Hand Gel Disney Princess Ariel ALCOHOL Bath & Body Works, Inc. 38e2113f-2fce-90f7-e063-6394a90a754c 2026-03-09 Warnings Name fallback generic name: ALCOHOL Anti-BacterialHandSpray Sweater Weather ALCOHOL Bath & Body Works, Inc. 4629294b-c756-6477-e063-6294a90a3d5d 2026-03-09 Warnings Name fallback generic name: ALCOHOL Anti Bacterial Hand Gel Disney Villains Maleficent ALCOHOL Bath & Body Works, Inc. 45c39e1e-e48c-a285-e063-6294a90ac2c7 2026-03-09 Warnings Name fallback generic name: ALCOHOL Anti Bacterial Hand Gel In The Stars ALCOHOL Bath & Body Works, Inc. 45c4cd42-cdde-4e07-e063-6394a90a2a0f 2026-03-09 Warnings Name fallback generic name: ALCOHOL Anti Bacterial Hand Gel Strawberry Snowflakes ALCOHOL Bath & Body Works, Inc. 46135c55-58fb-fe01-e063-6394a90ac415 2026-03-09 Warnings Name fallback generic name: ALCOHOL Anti Bacterial Hand Gel Pumpkin Pecan Waffles ALCOHOL Bath & Body Works, Inc. 45c6b183-8dce-8120-e063-6394a90abdc9 2026-03-09 Warnings Name fallback generic name: ALCOHOL Anti Bacterial Hand Gel Sweater Weather ALCOHOL Bath & Body Works, Inc. 45c7071a-7a05-7ba1-e063-6294a90af89e 2026-03-09 Warnings Name fallback generic name: ALCOHOL Anti Bacterial Hand Gel Vanilla Bean Noel ALCOHOL Bath & Body Works, Inc. 45c75b3d-c267-203f-e063-6394a90ae7b4 2026-03-09 Warnings Name fallback generic name: ALCOHOL
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.