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 36 of 83 · 1,660 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Protecting FHS ALCOHOL Ecolab 50d1e501-c143-4446-84e7-7f3f278166af 2025-12-30 Warnings Name fallback generic name: ALCOHOL Facilipro Protecting FHS ALCOHOL Ecolab d6fccda4-f565-406b-aeb6-585b59bddf51 2025-12-30 Warnings Name fallback generic name: ALCOHOL Retail Hand Sanitizer ALCOHOL Ecolab Inc. 55e65545-9869-413b-8239-bd2d43fe36d8 2025-12-30 Warnings Name fallback generic name: ALCOHOL Refreshify Antiseptic Hand Wipes ALCOHOL Emes Commerce Group Inc. 46d2f10e-e1c2-3ca2-e063-6394a90a602d 2025-12-29 Warnings Name fallback generic name: ALCOHOL Hand Sanitizer ALCOHOL HAIAN KANGRUI TEXTILE CO., LTD. 4711fb91-8afd-e5db-e063-6394a90a4b9e 2025-12-29 Warnings Name fallback generic name: ALCOHOL Dehydrated Alcohol ALCOHOL Ajenat Pharmaceuticals LLC 636d6421-cadf-42b3-a431-ba40c06e36d2 2025-12-29 Warnings, Adverse reactions Name fallback generic name: ALCOHOL StellaLife Hand Sanitizer ALCOHOL StellaLife, Inc. a65b338d-5019-0cfc-e053-2a95a90ae8b2 2025-12-26 Warnings Name fallback generic name: ALCOHOL VibeMist HYDRATING HAND SANITIZER Lavender Chamomile ALCOHOL Tazza Brands East Inc. 3c9afa9e-5109-bd0b-e063-6394a90ad8e5 2025-12-25 Warnings Name fallback generic name: ALCOHOL VibeMist HYDRATING HAND SANITIZER Peppermint Lemon ALCOHOL Tazza Brands East Inc. 3ddd9fa7-5e24-0781-e063-6394a90ae951 2025-12-25 Warnings Name fallback generic name: ALCOHOL VibeMist HYDRATING HAND SANITIZER Sweet Orange Vanilla Spice ALCOHOL Tazza Brands East Inc. 3dddc20c-5dba-2e19-e063-6394a90aac7f 2025-12-25 Warnings Name fallback generic name: ALCOHOL VibeMist HYDRATING HAND SANITIZER UNSCENTED ALCOHOL Tazza Brands East Inc. 3de26f8e-83ea-c04f-e063-6294a90ac024 2025-12-25 Warnings Name fallback generic name: ALCOHOL Tazza 70% Alcohol-Based Hand Sanitizing Foam ALCOHOL Tazza Brands East, Inc. 33452d7a-0436-99bb-e063-6294a90ad8c4 2025-12-24 Warnings Name fallback generic name: ALCOHOL tazza-X EXTREME 63% alcohol formula HAND SANITIZING ALCOHOL Tazza Brands East Inc. 3a073e9c-d6e6-e2d9-e063-6394a90a6153 2025-12-24 Warnings Name fallback generic name: ALCOHOL Alcare Plus Foamed Antiseptic Handrub ALCOHOL SC Johnson Professional USA, Inc. 56900a58-b586-41e5-8b66-c9a006a79a9b 2025-12-22 Warnings Name fallback generic name: ALCOHOL Alcare Antiseptic Handrub ALCOHOL SC Johnson Professional USA, Inc. 26afc6c3-125e-4937-9747-a619105af1ad 2025-12-22 Warnings Name fallback generic name: ALCOHOL PURELL Healthcare Advanced Hand Sanitizer Gentle and Free Foam ALCOHOL GOJO Industries, Inc. 74a190b2-6ba6-4cd3-99fb-0a4450eb3f37 2025-12-19 Warnings Name fallback generic name: ALCOHOL PURELL Professional Advanced Hand Sanitizer Fragrance Free Gel ALCOHOL GOJO Industries, Inc. 4952bb21-fefa-4ae1-8e1a-feb412ce100c 2025-12-19 Warnings Name fallback generic name: ALCOHOL PSSI E-San ALCOHOL Safe Foods Chemical Innovations b688591a-8eea-f1ac-e053-2995a90aabac 2025-12-18 Warnings Name fallback generic name: ALCOHOL Safeguard Hand Sanitizer ALCOHOL The Procter & Gamble Manufacturing Company 8ed8ec4c-6b9c-4441-a1f1-de8b72cd8d7a 2025-12-18 Warnings Name fallback generic name: ALCOHOL Alcohol ALCOHOL Dynarex Corporation 88c5dcbe-185f-4966-b98b-25d50299e8df 2025-12-18 Warnings Name fallback generic name: ALCOHOL
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.