IDkit HP ONE

Meridian Bioscience Israel Ltd🇺🇸 United States

FDA Page

Effective Date: Jul 28, 2026
Approval ID: 8baab7a7-5d20-46ad-9c4a-762992ef6b51
Products: 1 registered
Version: 6

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use IDKIT HP ONE AND IDKIT HP TWO safely and effectively. See full prescribing information for IDKIT HP ONE AND IDKIT HP TWO. IDKIT HP One (C-urea tablet for oral solution; Citrica (citric acid) for oral solution), co-packaged IDKIT HP Two (C-urea tablet for oral solution; Citrica (citric acid) for oral solution), co-packaged Initial U.S. Approval: 2002

Quick Stats

Total Products1

Labelers2

Label Sections2

Regulatory Agency

🇺🇸

U.S. Food and Drug Administration

United States

Data Sources & Disclaimer: Approval information is sourced from official FDA databases. This content is for informational purposes only and does not constitute medical or regulatory advice. Always refer to official FDA websites for the most current information.