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 23 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 Cinnamon Sugar Pretzel Cookie ALCOHOL Bath & Body Works, Inc. 4691401f-e697-898a-e063-6394a90a8d32 2026-03-10 Warnings Name fallback generic name: ALCOHOL Anti Bacterial Hand Gel To The Moon ALCOHOL Bath & Body Works, Inc. 46914e57-f085-e6cd-e063-6294a90a6fc4 2026-03-10 Warnings Name fallback generic name: ALCOHOL Anti-BacterialHandSpray Winter Candy Apple ALCOHOL Bath & Body Works, Inc. 463f7ab4-e5f3-ab23-e063-6394a90a541b 2026-03-10 Warnings Name fallback generic name: ALCOHOL Anti Bacterial Hand Gel Marshmallow Pumpkin Latte ALCOHOL Bath & Body Works, Inc. 4650a56b-c159-b228-e063-6394a90a5a6e 2026-03-10 Warnings Name fallback generic name: ALCOHOL Anti Bacterial Hand Gel Bright Christmas Morning ALCOHOL Bath & Body Works, Inc. 4650bf54-c759-f503-e063-6294a90a1d2e 2026-03-10 Warnings Name fallback generic name: ALCOHOL Anti Bacterial Hand Gel Cookie Butter Truffle ALCOHOL Bath & Body Works, Inc. 468c92f6-9cae-0c6e-e063-6394a90a78ef 2026-03-10 Warnings Name fallback generic name: ALCOHOL Anti Bacterial Hand Gel Mrs. Claus Cocktail ALCOHOL Bath & Body Works, Inc. 468c93d1-8265-7cd2-e063-6294a90a5776 2026-03-10 Warnings Name fallback generic name: ALCOHOL Anti Bacterial Hand Gel Fresh Sparkling Snow ALCOHOL Bath & Body Works, Inc. 468c9682-6163-830f-e063-6294a90a76a9 2026-03-10 Warnings Name fallback generic name: ALCOHOL Anti-BacterialHandSpray White Tea and Sage ALCOHOL Bath & Body Works, Inc. 463fc2a9-742a-fbd3-e063-6394a90a0bf9 2026-03-10 Warnings Name fallback generic name: ALCOHOL Anti Bacterial Hand Gel Twisted Peppermint ALCOHOL Bath & Body Works, Inc. 4650b8b0-87be-8c88-e063-6394a90a52ed 2026-03-10 Warnings Name fallback generic name: ALCOHOL Anti Bacterial Hand Gel Cereal Milk Soft Serve ALCOHOL Bath & Body Works, Inc. 469140f3-24ed-88e5-e063-6394a90a2f51 2026-03-10 Warnings Name fallback generic name: ALCOHOL Anti Bacterial Hand Gel Peppermint Bark Truffle ALCOHOL Bath & Body Works, Inc. 469149e2-656a-cb52-e063-6294a90ad50c 2026-03-10 Warnings Name fallback generic name: ALCOHOL Anti Bacterial Hand Gel Pumpkin Apple ALCOHOL Bath & Body Works, Inc. 4650ae83-ed71-a7aa-e063-6294a90ad109 2026-03-10 Warnings Name fallback generic name: ALCOHOL Anti Bacterial Hand Gel Fresh Rainfall ALCOHOL Bath & Body Works, Inc. 4650bbda-1646-da3a-e063-6294a90a67fa 2026-03-10 Warnings Name fallback generic name: ALCOHOL Anti Bacterial Hand Gel Blackberries and Basil ALCOHOL Bath & Body Works, Inc. 4650ab55-8ce4-a5e1-e063-6294a90a79bf 2026-03-10 Warnings Name fallback generic name: ALCOHOL Anti Bacterial Hand Gel Leaves ALCOHOL Bath & Body Works, Inc. 4650ae83-ed72-a7aa-e063-6294a90ad109 2026-03-10 Warnings Name fallback generic name: ALCOHOL Anti Bacterial Hand Gel Tis The Season ALCOHOL Bath & Body Works, Inc. 468c9ecb-1691-1e20-e063-6394a90a2e89 2026-03-10 Warnings Name fallback generic name: ALCOHOL Anti Bacterial Hand Gel Raspberry Holiday Pie Bar ALCOHOL Bath & Body Works, Inc. 4691409f-30e6-799b-e063-6394a90a34cd 2026-03-10 Warnings Name fallback generic name: ALCOHOL Anti Bacterial Moisturizing Hand Sanitizer Snowy Peach Berry ALCOHOL Bath & Body Works, Inc. 4690a5fd-79cf-e1fd-e063-6294a90a009c 2026-03-10 Warnings Name fallback generic name: ALCOHOL Anti Bacterial Hand Gel Milk Bar Birthday Cake ALCOHOL Bath & Body Works, Inc. 469140f3-24ec-88e5-e063-6394a90a2f51 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.