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 55 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 Cookie Butter Truffle ALCOHOL Bath & Body Works, Inc. 2b0f525b-ff60-9160-e063-6394a90a4cc1 2025-01-06 Warnings Name fallback generic name: ALCOHOL Anti Bacterial Hand Gel Bright Christmas Morning ALCOHOL Bath & Body Works, Inc. 2b0f4b8f-b042-8f98-e063-6394a90ac9b7 2025-01-06 Warnings Name fallback generic name: ALCOHOL Anti Bacterial Hand Gel Vanilla Icicles ALCOHOL Bath & Body Works, Inc. 2b0f3f65-746f-44ea-e063-6294a90a9185 2025-01-06 Warnings Name fallback generic name: ALCOHOL Anti Bacterial Hand Gel Bubbly Rose ALCOHOL Bath & Body Works, Inc. 2b1164fb-f6d5-5962-e063-6294a90a7297 2025-01-06 Warnings Name fallback generic name: ALCOHOL Anti Bacterial Hand Gel Macaron Cloud ALCOHOL Bath & Body Works, Inc. 2b115325-4268-5687-e063-6294a90ac6f8 2025-01-06 Warnings Name fallback generic name: ALCOHOL Anti Bacterial Hand Gel Party Dress ALCOHOL Bath & Body Works, Inc. 2b1171f1-f4b2-ce4b-e063-6394a90a7c82 2025-01-06 Warnings Name fallback generic name: ALCOHOL Anti Bacterial Hand Gel White Oak and Vanilla ALCOHOL Bath & Body Works, Inc. 2b11647a-ed9c-1c26-e063-6394a90a29b9 2025-01-06 Warnings Name fallback generic name: ALCOHOL Anti Bacterial Hand Gel Coconut Mint Drop ALCOHOL Bath & Body Works, Inc. 2b1132db-93f1-f73a-e063-6294a90a1e6f 2025-01-06 Warnings Name fallback generic name: ALCOHOL Anti Bacterial Hand Gel Cranberry Pear Bellini ALCOHOL Bath & Body Works, Inc. 2b113330-d619-ef15-e063-6394a90ac3fe 2025-01-06 Warnings Name fallback generic name: ALCOHOL Hand Sanitizer ALCOHOL CASAD Company, Inc 1e314157-c64e-492a-89ad-2b28831d551d 2025-01-03 Warnings Name fallback generic name: ALCOHOL Anti Bacterial Hand Gel Lavender Cloud ALCOHOL Bath & Body Works, Inc. 29ba1fca-5ec9-b0f7-e063-6294a90a7bd1 2025-01-02 Warnings Name fallback generic name: ALCOHOL Anti Bacterial Hand Gel Winter Candy Apple ALCOHOL Bath & Body Works, Inc. 29ba15a4-8de6-e97f-e063-6394a90a6c9a 2025-01-02 Warnings Name fallback generic name: ALCOHOL Anti Bacterial Hand Gel Vanilla Bean Noel ALCOHOL Bath & Body Works, Inc. 29ba3284-3ea7-7332-e063-6394a90ad19a 2025-01-02 Warnings Name fallback generic name: ALCOHOL Anti Bacterial Hand Gel Strawberry Soda ALCOHOL Bath & Body Works, Inc. 29ba304b-5714-b2a4-e063-6294a90ac761 2025-01-02 Warnings Name fallback generic name: ALCOHOL Total Solutions Hand Sanitizing Wipes ALCOHOL Athea Laboratories, Inc. 2dd15f06-5ca6-524d-e063-6294a90a277e 2025-01-01 Warnings Name fallback generic name: ALCOHOL Hand Sanitizer ALCOHOL Lil' Drug Store Products, Inc c8c75368-b27d-47a6-bb73-35b15abc3211 2024-12-31 Warnings Name fallback generic name: ALCOHOL Hand Sanitizer ALCOHOL Lil' Drug Store Products, Inc. 1bb77439-c2b4-431d-8c3b-e78b5431a18a 2024-12-31 Warnings Name fallback generic name: ALCOHOL Hillyard Foaming Instant Hand Sanitizer ALCOHOL Hillyard GMP 4acdbf3e-fa79-468f-9e18-fcf9b1f35707 2024-12-30 Warnings Name fallback generic name: ALCOHOL MedBox Hand Sanitizer ALCOHOL Harpers Pharmacy, Inc. f66c6abe-161c-48fa-8736-0abf97c3799a 2024-12-20 Warnings Name fallback generic name: ALCOHOL Perk Hand Sanitizer Moisturizing Gel ALCOHOL Worklifebrands LLC 18da87cf-6f59-41c6-a1da-cf32267f7de5 2024-12-20 Warnings Name fallback generic name: ALCOHOL
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.