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 33 of 83 · 1,660 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Covex Antibacterial Hand Sanitizer, COOL BREEZE ALCOHOL DALAN KIMYA ENDUSTRI ANONIM SIRKETI a2a1587e-1ae1-d34b-e053-2995a90a2ce9 2026-01-22 Warnings Name fallback generic name: ALCOHOL Covex Antibacterial Hand Sanitizer, FRESH ALOE ALCOHOL DALAN KIMYA ENDUSTRI ANONIM SIRKETI a2a19dd5-57b2-6c98-e053-2a95a90a96cd 2026-01-22 Warnings Name fallback generic name: ALCOHOL Hand Sanitizing Wipes ALCOHOL Germs Be Gone LLC 2bd6249b-f215-7aa9-e063-6394a90a6580 2026-01-20 Warnings Name fallback generic name: ALCOHOL Scent Theory Hand Sanitizers Coastal Mist, Boardwalk Treats, Firecracker Freeze ALCOHOL Scent Theory Products LLC 48c3d5e9-2d57-5a46-e063-6394a90a0722 2026-01-19 Warnings Name fallback generic name: ALCOHOL Instant Hand Sanitizer ALCOHOL Safetec of America, Inc. c3f0556d-f967-4f19-922c-57a2bf184892 2026-01-16 Warnings Name fallback generic name: ALCOHOL Instant Hand Sanitizer ALCOHOL Safetec of America 3b5b46d0-308a-4649-8384-246da3a18ba1 2026-01-16 Warnings Name fallback generic name: ALCOHOL Instant Hand Sanitizer ALCOHOL Safetec of America bf69cc74-ebe9-40c3-a95a-a489492cc693 2026-01-16 Warnings Name fallback generic name: ALCOHOL Perk Hand Sanitizer with Moisturizers ALCOHOL Worklifebrands LLC 4846937f-905e-faec-e063-6394a90a77a2 2026-01-13 Warnings Name fallback generic name: ALCOHOL Hand Sanitizer ALCOHOL Saje Natural Business Inc. a70da1c6-4ca6-b801-e053-2a95a90ae1a5 2026-01-13 Warnings Name fallback generic name: ALCOHOL Instant Hand Sanitizer ALCOHOL Hydrox Laboratories a818def4-f6e9-4a97-aa26-b7c082ae8d18 2026-01-12 Warnings Name fallback generic name: ALCOHOL Instant Hand Sanitizer ALCOHOL Hydrox Laboratories 285505b0-ee49-4d01-9019-1052e2fb1964 2026-01-12 Warnings Name fallback generic name: ALCOHOL Instant Hand Sanitizer Unscented ALCOHOL Hydrox Laboratories cd42da2c-0235-4410-945b-baabb5c7931b 2026-01-12 Warnings Name fallback generic name: ALCOHOL Instant Hand Sanitizer ALCOHOL LTC Products Inc. 6c16aeec-bef2-41f1-b22d-ac37c3625562 2026-01-12 Warnings Name fallback generic name: ALCOHOL PURELL Advanced Hand Sanitizer be Peaceful ALCOHOL GOJO Industries, Inc. 45810c51-8738-4b8a-8d8f-46b4b41dbe93 2026-01-12 Warnings Name fallback generic name: ALCOHOL PURELL Advanced Hand Sanitizer be Vibrant ALCOHOL GOJO Industries, Inc. 3a991a7f-1289-4aeb-82f9-8cebd6a389b5 2026-01-12 Warnings Name fallback generic name: ALCOHOL Purell Advanced Refreshing ALCOHOL GOJO Industries, Inc. b1beadc4-5cf4-4e28-90cc-3f9fdc132a90 2026-01-12 Warnings Name fallback generic name: ALCOHOL PURELL Advanced Instant Hand Sanitizer ALCOHOL GOJO Industries, Inc. 3c3b14e1-4a9d-4ebb-b6b6-ab0173ac06e5 2026-01-12 Warnings Name fallback generic name: ALCOHOL Safety 1st Social Safety Pack ALCOHOL Dorel Juvenile Inc. ada382f5-5925-37ce-e053-2a95a90af65d 2026-01-09 Warnings Name fallback generic name: ALCOHOL Safety 1st Oh Sh t Kit ALCOHOL Dorel Juvenile Inc. b142009c-8276-e2fd-e053-2a95a90aad16 2026-01-09 Warnings Name fallback generic name: ALCOHOL Instant Hand Sanitizeing Wipe ALCOHOL SHANDONG HENGFA HYGIENIC PRODUCTS CO., LTD. bd17c0c7-d824-6b03-e053-2995a90afe15 2026-01-08 Warnings Name fallback generic name: ALCOHOL
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.