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 8 of 83 · 1,660 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Scentfull Hand Sanitizer Blue Driftwood ALCOHOL Scent Theory Products LLC 56572ebe-d624-6389-e063-6394a90a23b4 2026-07-11 Warnings Name fallback generic name: ALCOHOL Purell Advanced Soothing ALCOHOL GOJO Industries, LLC 59b47629-8b4e-4084-8bc8-66c7e5599e9c 2026-07-10 Warnings Name fallback generic name: ALCOHOL PURELL Advanced Hand Sanitizer Gentle and Free Foam ALCOHOL GOJO Industries, LLC 70b13f86-4d1a-4221-b09d-7438163fe9b5 2026-07-10 Warnings Name fallback generic name: ALCOHOL PURELL Advanced Hand Sanitizer Fragrance Free Foam ALCOHOL GOJO Industries, LLC 63c26f36-4bae-4cce-bacb-d0da66b228f7 2026-07-10 Warnings Name fallback generic name: ALCOHOL NatureWell Hydrating Hand Sanitizer Fresh Squeeze ALCOHOL American Exchange Group 6a668197-1fa8-4c07-a520-20e194df39c5 2026-07-10 Warnings Name fallback generic name: ALCOHOL NatureWell Hydrating Hand Sanitizer, Paradise Please ALCOHOL American Exchange Group 6d75c795-ff84-4775-8f7d-a2416acf845e 2026-07-10 Warnings Name fallback generic name: ALCOHOL NatureWell Hydrating Hand Sanitizer, Hinoki Hour ALCOHOL American Exchange Group 303866ab-8b9f-4e74-8408-62e57bb731d7 2026-07-10 Warnings Name fallback generic name: ALCOHOL NatureWell Hydrating Hand Sanitizer, Pineapple Pop ALCOHOL American Exchange Group 20aa290f-39e4-4bc9-9128-d6268d8d74d0 2026-07-10 Warnings Name fallback generic name: ALCOHOL NatureWell Hydrating Hand Sanitizer Vanilla Daydream ALCOHOL American Exchange Group a188f0ef-75fa-4ace-8712-7ce592ae1957 2026-07-10 Warnings Name fallback generic name: ALCOHOL NatureWell Hydrating Hand Sanitizer Clean Girl ALCOHOL American Exchange Group f5588dff-3299-47c5-a570-94c346b6b2e9 2026-07-10 Warnings Name fallback generic name: ALCOHOL PURELL Advanced Hand Sanitizer Biobased Content ALCOHOL GOJO Industries, LLC 60584888-a800-4825-85b3-cf55ca7c045e 2026-07-09 Warnings Name fallback generic name: ALCOHOL Hand Sanitizer gel ALCOHOL EverywhereAire LLC d2a6c866-3f1e-20f1-e053-2995a90a26cc 2026-07-06 Warnings Name fallback generic name: ALCOHOL Family Beauty Hydrating Hand Sanitizer Watermelon Scented ALCOHOL Family Dollar Stores, Inc. efe9989b-b729-439d-8489-3a100abcf821 2026-07-02 Warnings Name fallback generic name: ALCOHOL Family Beauty Hydrating Hand Sanitizer, Cucumber and Melon Scented ALCOHOL Family Dollar Stores, Inc. dbd29c6e-fa01-49ad-a673-66b25f558ad4 2026-07-02 Warnings Name fallback generic name: ALCOHOL Family Beauty Hydrating Hand Sanitizer, Coconut Scented ALCOHOL Family Dollar Stores, Inc. 35ce4c48-f260-4306-a886-add12820ac78 2026-07-02 Warnings Name fallback generic name: ALCOHOL Anti-BacterialHandSpray Berry Bliss ALCOHOL Bath & Body Works, Inc. 55935d41-ce7a-796a-e063-6294a90a6ba2 2026-07-01 Warnings Name fallback generic name: ALCOHOL Anti-BacterialHandSpray Tangerine Twirl ALCOHOL Bath & Body Works, Inc. 55933da8-dfbc-6877-e063-6394a90abb7f 2026-07-01 Warnings Name fallback generic name: ALCOHOL Anti-BacterialHandSpray Watermelon Whirl ALCOHOL Bath & Body Works, Inc. 559364cc-2b55-9628-e063-6394a90ac8e6 2026-07-01 Warnings Name fallback generic name: ALCOHOL Laura Lynn Moisturizing Advanced Gel Hand Sanitizer ALCOHOL Ingles Markets, Inc. 57ebcdd5-09fd-74ce-e063-6294a90af0a1 2026-07-01 Warnings Name fallback generic name: ALCOHOL Gel Hand Sanitizer ALCOHOL Intercon Chemical Company 5579be7d-1674-5602-e063-6394a90a8169 2026-06-30 Warnings Name fallback generic name: ALCOHOL
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.