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 77 of 82 · 1,638 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Justice Glitter Berry Scented Anti-bacterial Hand Sanitizer A ALCOHOL Tween Brands, Inc. fb1e3ba8-7b82-4bff-9261-e0a6f3dba310 2023-10-26 Warnings Name fallback generic name: ALCOHOL berries and cream hand sanitizer ALCOHOL Target Corporation c5731cb4-e79a-46af-b5bc-bcf01ea4c5de 2023-10-26 Warnings Name fallback generic name: ALCOHOL Instant HAND SANITIZER ALCOHOL Xact Xpressions f166447d-95c1-4419-a7d1-e0dcb64d4f48 2023-10-26 Warnings Name fallback generic name: ALCOHOL Justice Rainbow Raspberry Scented Anti-bacterial Hand Sanitizer ALCOHOL Tween Brands, Inc. 6b0ec518-52c9-4882-aa72-eb4e3064c77f 2023-10-26 Warnings Name fallback generic name: ALCOHOL Justice Vanilla Vibes Scented Anti-bacterial Hand Sanitizer ALCOHOL Tween Brands, Inc. b85cec1d-d999-464b-8c7f-480e642b857c 2023-10-26 Warnings Name fallback generic name: ALCOHOL RASPBERRY SCENTED HAND SANITIZER ALCOHOL Target Brands,Inc. 9bcc62bb-b691-d3ca-e053-2a95a90a284d 2023-10-26 Warnings Name fallback generic name: ALCOHOL Justice Moonstone Melon Scented Antibacterial Hand Sanitizer ALCOHOL Tween Brands,Inc. 9bcbcf14-b541-089a-e053-2995a90ac6a5 2023-10-26 Warnings Name fallback generic name: ALCOHOL Justice Diamond Vanilla Scented Antibacterial Hand Sanitizer ALCOHOL Tween Brands,Inc. 9bcba4da-d3e8-d4c2-e053-2a95a90a432f 2023-10-26 Warnings Name fallback generic name: ALCOHOL Justice Cranberry Scented Anti-bacterial Hand Sanitizer ALCOHOL Tween Brands, Inc. a912368d-58c5-4479-98d4-ca06496c4ea4 2023-10-26 Warnings Name fallback generic name: ALCOHOL Justice Bubbling Blueberry Scented Anti-bacterial Hand Sanitizer ALCOHOL Tween Brands, Inc. 0cc54cfb-f426-4669-9f65-95e167ffa0d9 2023-10-26 Warnings Name fallback generic name: ALCOHOL Watermelon Wonder Hand Sanitizer ALCOHOL Target Corporation 2872bd4b-854b-4041-ab04-ccb5b55f1be2 2023-10-26 Warnings Name fallback generic name: ALCOHOL Justice Rainbow Berry Scented Anti-bacterial Hand Sanitizer ALCOHOL Tween Brands, Inc. 113797a1-fcb1-47ee-a488-770c130b9b1e 2023-10-26 Warnings Name fallback generic name: ALCOHOL Justice Rainbow Raspberry Scented Antibacterial Hand Sanitizer ALCOHOL Tween Brands,Inc. 9bcbb359-cdd7-d9ad-e053-2a95a90a65ff 2023-10-26 Warnings Name fallback generic name: ALCOHOL ROSE SCENTED HAND SANITIZER ALCOHOL Target Brands,Inc. 9bcc3e8d-abd9-bca2-e053-2a95a90a719e 2023-10-26 Warnings Name fallback generic name: ALCOHOL black cherry champ hand sanitizer ALCOHOL Target Corporation cee87726-fe4c-48b2-9037-025b35d1ab42 2023-10-26 Warnings Name fallback generic name: ALCOHOL melon mango melt hand sanitizer ALCOHOL Target Corporation 640f48c8-3b23-4809-ad15-26fe66fb0e40 2023-10-26 Warnings Name fallback generic name: ALCOHOL Justice be Happy Citrus Scented Antibacterial Hand Sanitizer ALCOHOL Tween Brands,Inc. 9bcbb5c8-ad8f-1f32-e053-2995a90a6d6e 2023-10-26 Warnings Name fallback generic name: ALCOHOL Justice Vanilla Scented Anti-bacterial Hand Sanitizer ALCOHOL TWEEN BRANDS, INC 0d61d7a1-f222-4799-a632-87d0a9562713 2023-10-26 Warnings Name fallback generic name: ALCOHOL cranberry chill hand sanitizer ALCOHOL Target Corporation 99df23be-7c02-462b-b7dc-db267f9190cc 2023-10-26 Warnings Name fallback generic name: ALCOHOL Justice Sparkling Strawberry Scented Anti-bacterial Hand Sanitizer ALCOHOL Tween Brands, Inc. ab3109bc-1ab5-41cf-b9e1-262ae504eae1 2023-10-26 Warnings Name fallback generic name: ALCOHOL
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.