Active substance
Urea c 13
- US FDA 4
- Safety 1
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| MERETEK UBT KIT (W/ PRANACTIN) | 125MG/VIAL | for solution · oral | OTSUKA AMERICA | Discontinued | 17 Sep 1996 |
| BREATHTEK UBT FOR H-PYLORI | EQ 75MG/POUCH | for solution · oral | OTSUKA AMERICA | Discontinued | 17 Sep 1996 |
| PYLORI-CHEK BREATH TEST | 100MG/VIAL | for solution · oral | DXS DEVICES | Discontinued | 4 Feb 1999 |
| HELICOSOL | 125MG/VIAL | for solution · oral | METABOLIC SOLUTIONS | Discontinued | 17 Dec 1999 |
Safety signals and safety-related labeling changes
- US FDA 24 Jul 2026 IDKIT:HP — safety-related labeling change
Labeling sections changed: Use in Specific Populations
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.