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 53 of 82 · 1,638 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Hand sanitizer 29ml 01 ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. eb5d6739-ee36-cd74-e053-2a95a90ab659 2025-02-05 Warnings Name fallback generic name: ALCOHOL Hand sanitizer 29ml 01 ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 037b4acb-49ca-bc0a-e063-6394a90a1fcc 2025-02-05 Warnings Name fallback generic name: ALCOHOL AWAS ALCOHOLSPRAY ALCOHOL IDO PHARM 03010837-0289-3e08-e063-6394a90a7d04 2025-01-30 Warnings Name fallback generic name: ALCOHOL Antiseptic ALCOHOL Welly Health PCB 85ce2c23-25d8-4b35-95ff-99f098d92bc9 2025-01-29 Warnings Name fallback generic name: ALCOHOL On Guard Sanitizing Gel ALCOHOL doTERRA International, LLC e4b8b4bb-1d47-6826-e053-2a95a90ab168 2025-01-28 Warnings Name fallback generic name: ALCOHOL Easy Care Hand Sanitizer ALCOHOL GFA Production (Xiamen) Co., Ltd. c7058806-ad4e-6d5f-e053-2a95a90a35e8 2025-01-27 Warnings Name fallback generic name: ALCOHOL PHARMACYS PRESCRIPTION 8OZ HAND SANITIZER ALCOHOL American Consumer Products Corp 7a048607-f4c3-6724-e053-2a91aa0ab6f2 2025-01-23 Warnings Name fallback generic name: ALCOHOL SANITAXE 27 OZ INSTANT HAND SANITIZER WITH ALOE VERA ALCOHOL American Consumer Products Corp a8f00148-b8fa-6c4f-e053-2995a90ac5e2 2025-01-23 Warnings Name fallback generic name: ALCOHOL KeriCure Hand Sanitizer ALCOHOL Kericure Inc. 40d283ad-38a8-4ee6-bcba-56ccb99f7ee6 2025-01-22 Warnings Name fallback generic name: ALCOHOL KeriCure Hand Sanitizer ALCOHOL Kericure Inc. de516d2e-9c16-4bd2-b4c2-7e2f9fd26442 2025-01-22 Warnings Name fallback generic name: ALCOHOL KeriCure Hand Sanitizer ALCOHOL Kericure Inc. caa98aaa-1307-41df-a59d-258e1edd3081 2025-01-22 Warnings Name fallback generic name: ALCOHOL Hand Sanitizer Wipes ALCOHOL HANUL CO.,LTD a3424b96-74b0-21c4-e053-2a95a90ae7ea 2025-01-20 Warnings Name fallback generic name: ALCOHOL Hand Sanitizer Wipes ALCOHOL HANUL CO.,LTD a4eb1cad-a9c0-43d3-e053-2995a90a06a0 2025-01-20 Warnings Name fallback generic name: ALCOHOL RICO Hand Sanitizer Wipes ALCOHOL HANUL CO.,LTD dc8ba3a2-9748-ec52-e053-2995a90a638b 2025-01-20 Warnings Name fallback generic name: ALCOHOL Hand Sanitizer ALCOHOL HANUL CO.,LTD a4fa65f9-9786-76dd-e053-2995a90a6e13 2025-01-20 Warnings Name fallback generic name: ALCOHOL Rico Hand Sanitizer ALCOHOL HANUL CO.,LTD a6065fcd-3968-d5a1-e053-2a95a90ab8d6 2025-01-20 Warnings Name fallback generic name: ALCOHOL Smart Care Sanitizer Spray. 01 ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 1b125c5d-7041-c71b-e063-6394a90add9b 2025-01-17 Warnings Name fallback generic name: ALCOHOL Berry Hand Sanitizer Spray. 01 ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 1f128054-4c57-8055-e063-6294a90adc4e 2025-01-17 Warnings Name fallback generic name: ALCOHOL Hand Sanitizer ALCOHOL CMC Group Inc. dcca50e6-0935-401d-a23e-be4d1231dde9 2025-01-13 Warnings Name fallback generic name: ALCOHOL Antibacterial ALCOHOL Henry Schein Inc. 87446203-1365-49b6-9346-62fb8ec78311 2025-01-10 Warnings Name fallback generic name: ALCOHOL
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.