FDA Approval: IDKIT HP ONE (CITRIC ACID ANHYDROUS AND 13C UREA) — Type 3 - New Dosage Form
Policy FDA-NDA021314 · Gastroenterology
IDKIT HP ONE (citric acid anhydrous and 13C urea) is an oral diagnostic agent approved for detecting Helicobacter pylori infection via the urea breath test. As an oral drug administered in an outpatie