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 56 of 82 · 1,638 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Alcare OR Foamed Antiseptic Handrub ALCOHOL SC Johnson Professional USA, Inc. acc2f83f-6b9b-4552-8330-33e7b99397d8 2024-12-20 Warnings Name fallback generic name: ALCOHOL Anti-BacterialHandSpray Cinnamon Caramel Swirl ALCOHOL Bath & Body Works, Inc. 29a359ef-03c2-c9da-e063-6294a90a16c0 2024-12-19 Warnings Name fallback generic name: ALCOHOL Anti-BacterialHandSpray Mahogany Apple ALCOHOL Bath & Body Works, Inc. 29a37481-91e7-de08-e063-6294a90a46a7 2024-12-19 Warnings Name fallback generic name: ALCOHOL Anti-BacterialHandSpray Winter Candy Apple ALCOHOL Bath & Body Works, Inc. 29a3aa8a-c698-a873-e063-6294a90a72c4 2024-12-19 Warnings Name fallback generic name: ALCOHOL Anti-BacterialHandSpray Sun Washed Citrus ALCOHOL Bath & Body Works, Inc. 29a3af85-35b5-80eb-e063-6294a90aadfd 2024-12-19 Warnings Name fallback generic name: ALCOHOL Anti-BacterialHandSpray Cactus Blossom ALCOHOL Bath & Body Works, Inc. 29a39319-8d25-e86a-e063-6394a90a8a8c 2024-12-19 Warnings Name fallback generic name: ALCOHOL Anti-BacterialHandSpray Boardwalk Vanilla Cone ALCOHOL Bath & Body Works, Inc. 29a3b5b3-c104-7754-e063-6294a90af8e7 2024-12-19 Warnings Name fallback generic name: ALCOHOL Anti-BacterialHandSpray Sparkling Watermelon ALCOHOL Bath & Body Works, Inc. 29a3af99-8186-9ec6-e063-6294a90ab842 2024-12-19 Warnings Name fallback generic name: ALCOHOL Anti-BacterialHandSpray Vanilla Bean Noel ALCOHOL Bath & Body Works, Inc. 29a4f4f7-8ac5-383c-e063-6394a90ad2d5 2024-12-19 Warnings Name fallback generic name: ALCOHOL Anti-BacterialHandSpray Frosted Coconut Snowball ALCOHOL Bath & Body Works, Inc. 29a4feca-c287-51cb-e063-6294a90a264a 2024-12-19 Warnings Name fallback generic name: ALCOHOL Anti-BacterialHandSpray Twisted Peppermint ALCOHOL Bath & Body Works, Inc. 29a4ff29-e2ee-526c-e063-6294a90ad01b 2024-12-19 Warnings Name fallback generic name: ALCOHOL Anti Bacterial Hand Gel Pink Chiffon ALCOHOL Bath & Body Works, Inc. 29a539bb-42dd-dc73-e063-6394a90a5fe9 2024-12-19 Warnings Name fallback generic name: ALCOHOL Anti Bacterial Hand Gel White Pumpkin ALCOHOL Bath & Body Works, Inc. 29a536a0-3fb9-c35f-e063-6394a90ae1e3 2024-12-19 Warnings Name fallback generic name: ALCOHOL Anti Bacterial Hand Gel Together Weather ALCOHOL Bath & Body Works, Inc. 29a534f2-46cd-ea47-e063-6394a90a1319 2024-12-19 Warnings Name fallback generic name: ALCOHOL Anti Bacterial Hand Gel Rose Water and Ivy ALCOHOL Bath & Body Works, Inc. 29a539bb-42e2-dc73-e063-6394a90a5fe9 2024-12-19 Warnings Name fallback generic name: ALCOHOL Anti Bacterial Hand Gel Vanilla Romance ALCOHOL Bath & Body Works, Inc. 29a540fd-60b5-eb1e-e063-6394a90a27f7 2024-12-19 Warnings Name fallback generic name: ALCOHOL Anti Bacterial Hand Gel Flannel ALCOHOL Bath & Body Works, Inc. 29a54361-e108-20d7-e063-6294a90a117a 2024-12-19 Warnings Name fallback generic name: ALCOHOL Anti Bacterial Hand Gel Frozen Lake ALCOHOL Bath & Body Works, Inc. 29a536d5-6abb-c0ef-e063-6394a90a15bb 2024-12-19 Warnings Name fallback generic name: ALCOHOL Anti Bacterial Hand Gel Marshmallow Pumpkin Latte ALCOHOL Bath & Body Works, Inc. 29a5342a-e6dc-ea55-e063-6394a90a11e8 2024-12-19 Warnings Name fallback generic name: ALCOHOL Anti Bacterial Hand Gel Pumpkin Apple ALCOHOL Bath & Body Works, Inc. 29a536d5-6abf-c0ef-e063-6394a90a15bb 2024-12-19 Warnings Name fallback generic name: ALCOHOL
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.