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 66 of 82 · 1,638 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Anti Bacterial Hand Gel Pink Gumball ALCOHOL Bath & Body Works, Inc. 1ba4d76b-8e17-c44d-e063-6294a90a6dc1 2024-06-24 Warnings Name fallback generic name: ALCOHOL Anti Bacterial Hand Gel Pink Kiwi Berry ALCOHOL Bath & Body Works, Inc. 1ba5423f-3f64-7022-e063-6394a90a2554 2024-06-24 Warnings Name fallback generic name: ALCOHOL Anti Bacterial Hand Gel Pink Peach Blossom ALCOHOL Bath & Body Works, Inc. 1ba55871-7940-8d8f-e063-6394a90ac69b 2024-06-24 Warnings Name fallback generic name: ALCOHOL Anti Bacterial Hand Gel Pink Pineapple Sunrise ALCOHOL Bath & Body Works, Inc. 1ba582a1-ad40-33af-e063-6294a90a6b8a 2024-06-24 Warnings Name fallback generic name: ALCOHOL Anti Bacterial Hand Gel Pumpkin Pecan Waffles ALCOHOL Bath & Body Works, Inc. 1ba58ba5-5c96-f11e-e063-6394a90ad74f 2024-06-24 Warnings Name fallback generic name: ALCOHOL Anti Bacterial Hand Gel Queen Charlottes Tea ALCOHOL Bath & Body Works, Inc. 1ba599dc-53fc-3f65-e063-6294a90a1c83 2024-06-24 Warnings Name fallback generic name: ALCOHOL Anti Bacterial Hand Gel Raspberry Tangerine ALCOHOL Bath & Body Works, Inc. 1ba5ad26-6662-93a7-e063-6394a90a32e6 2024-06-24 Warnings Name fallback generic name: ALCOHOL Anti Bacterial Hand Gel Starfruit Sangria ALCOHOL Bath & Body Works, Inc. 1ba5c35b-3fff-f382-e063-6394a90a2230 2024-06-24 Warnings Name fallback generic name: ALCOHOL Anti Bacterial Hand Gel Strawberry Kiwi ALCOHOL Bath & Body Works, Inc. 1ba60a03-1ba6-e38b-e063-6294a90ac85e 2024-06-24 Warnings Name fallback generic name: ALCOHOL Anti Bacterial Hand Gel Sunny Lemon Orchard ALCOHOL Bath & Body Works, Inc. 1ba62030-2c45-b9ca-e063-6394a90a6173 2024-06-24 Warnings Name fallback generic name: ALCOHOL Anti Bacterial Hand Gel Sweet Apple ALCOHOL Bath & Body Works, Inc. 1ba62b8e-ecdc-6657-e063-6294a90a6cd2 2024-06-24 Warnings Name fallback generic name: ALCOHOL Anti Bacterial Hand Gel Sweet Cinnamon Pumpkin ALCOHOL Bath & Body Works, Inc. 1ba62d80-58ed-ef58-e063-6294a90ac36d 2024-06-24 Warnings Name fallback generic name: ALCOHOL Anti Bacterial Hand Gel Sunlit Palm Trees ALCOHOL Bath & Body Works, Inc. 1ba628e9-6abb-89a1-e063-6394a90aa5bc 2024-06-24 Warnings Name fallback generic name: ALCOHOL Anti Bacterial Hand Gel Tropidelic ALCOHOL Bath & Body Works, Inc. 1ba62cc3-020c-d3f8-e063-6394a90ac16a 2024-06-24 Warnings Name fallback generic name: ALCOHOL Anti Bacterial Hand Gel Sweet Orange Blossom ALCOHOL Bath & Body Works, Inc. 1ba6082b-42cb-e7de-e063-6294a90a993d 2024-06-24 Warnings Name fallback generic name: ALCOHOL Anti Bacterial Hand Gel Wisteria Garden ALCOHOL Bath & Body Works, Inc. 1ba69e52-2b70-6d06-e063-6394a90a6923 2024-06-24 Warnings Name fallback generic name: ALCOHOL Anti Bacterial Hand Gel Turquoise Waters ALCOHOL Bath & Body Works, Inc. 1ba6982d-6822-50ed-e063-6394a90a6ac9 2024-06-24 Warnings Name fallback generic name: ALCOHOL Anti Bacterial Hand Gel Vampire Blood ALCOHOL Bath & Body Works, Inc. 1ba67404-fecc-b089-e063-6394a90a20d9 2024-06-24 Warnings Name fallback generic name: ALCOHOL Anti Bacterial Hand Gel Wildberry French Toast ALCOHOL Bath & Body Works, Inc. 1ba6a663-9590-4f80-e063-6294a90ac1dd 2024-06-24 Warnings Name fallback generic name: ALCOHOL Anti Bacterial Hand Gel Lavender and Vanilla ALCOHOL Bath & Body Works, Inc. 1ba6a8d8-b081-bd38-e063-6294a90a44c2 2024-06-24 Warnings Name fallback generic name: ALCOHOL
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.