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 35 of 83 · 1,660 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Smart Care Hand Sanitizer Mermicorno ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 47af3ed6-971d-d749-e063-6294a90a1ee5 2026-01-05 Warnings Name fallback generic name: ALCOHOL Hand Sanitiser ALCOHOL Zhejiang Guoyao Jingyue Aerosol Co., Ltd. a44d82bf-68a3-56bc-e053-2995a90ae526 2026-01-05 Warnings Name fallback generic name: ALCOHOL Green Island Sanitiser ALCOHOL Zhejiang Guoyao Aerosol Co., Ltd a7d1df16-3566-badf-e053-2a95a90aa61a 2026-01-05 Warnings Name fallback generic name: ALCOHOL Smart Care Hand Sanitizer Mermicorno ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 47af97d6-ae84-adfe-e063-6394a90aa777 2026-01-05 Warnings Name fallback generic name: ALCOHOL Smart Care Hand Sanitizer Monster Jam ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 47afe5bd-5e06-7300-e063-6294a90a94e8 2026-01-05 Warnings Name fallback generic name: ALCOHOL Walgreens Hand Sanitizer watermelon ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 479b898c-0dff-98fe-e063-6294a90ade20 2026-01-04 Warnings Name fallback generic name: ALCOHOL Smart Care Hand Sanitizer Champagne Toast ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 479beac0-16bc-a88c-e063-6394a90a42f5 2026-01-04 Warnings Name fallback generic name: ALCOHOL Smart Care Hand Sanitizer with Silicone Case 3pk ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 478b0ba2-d8ce-8101-e063-6294a90a6464 2026-01-03 Warnings Name fallback generic name: ALCOHOL Quik-Care Nourishing Foam Hand Sanitizer ALCOHOL Ecolab Inc. f83bbb1f-b1a9-42cd-ae46-168815cfefb5 2026-01-02 Warnings Name fallback generic name: ALCOHOL CHEMSTAR RETAIL HAND SANITIZER ALCOHOL Ecolab Inc. 3d874e95-48d0-4383-97df-b97d54d1648c 2025-12-31 Warnings Name fallback generic name: ALCOHOL Hand Sanitizer ALCOHOL Astera International LLC a5189240-19ce-7715-e053-2995a90ad043 2025-12-31 Warnings Name fallback generic name: ALCOHOL SSDC Alphasan Hand Sanitizer ALCOHOL Ecolab Inc. bbb0f924-3224-47f0-85b2-ebe024f8f958 2025-12-31 Warnings Name fallback generic name: ALCOHOL Kay Alcohol Foam Hand Sanitizer ALCOHOL Ecolab Inc. 37429e8a-581d-443e-8e8a-71fbb53c7c56 2025-12-31 Warnings Name fallback generic name: ALCOHOL QSR Hand Sanitizer ALCOHOL Ecolab Inc. 901abea4-b82e-43c7-a1ac-0cdc1555dbc2 2025-12-31 Warnings Name fallback generic name: ALCOHOL Ecolab Retail Foaming Alcohol Hand Sanitizer ALCOHOL Ecolab Inc. e3f6eb96-05fe-4b20-bb72-954cdc47ffcb 2025-12-31 Warnings Name fallback generic name: ALCOHOL FIRST MARK ULTRA HAND SANITIZER ALCOHOL Performance Food Group 80a490b4-dae5-4851-b3e6-2e558cdc51e5 2025-12-30 Warnings Name fallback generic name: ALCOHOL Ecolab ALCOHOL Ecolab Inc. f8561810-9d12-4c05-a547-b41bbb5170a9 2025-12-30 Warnings Name fallback generic name: ALCOHOL PureForce ALCOHOL Ecolab Inc. 775ee6e6-b3f8-4b97-b2b1-6f3a2defc696 2025-12-30 Warnings Name fallback generic name: ALCOHOL Ecolab ALCOHOL Ecolab Inc. a02591df-f121-4b92-8d0a-d4ef5edce119 2025-12-30 Warnings Name fallback generic name: ALCOHOL Alcohol Gel Hand Sanitizer ALCOHOL Ecolab Inc. 6305da7a-f21c-4e94-a2c1-e1faac489df6 2025-12-30 Warnings Name fallback generic name: ALCOHOL
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.