FDA — authorised 17 September 1996
- Application: NDA020586
- Marketing authorisation holder: OTSUKA AMERICA
- Local brand name: BREATHTEK UBT FOR H-PYLORI
- Indication: FOR SOLUTION — ORAL
- Status: approved
🇺🇸 UREA C 13 in United States
FDA authorised UREA C 13 on 17 September 1996
Marketing authorisations
FDA — authorised 17 December 1999
- Application: NDA021092
- Marketing authorisation holder: METABOLIC SOLUTIONS
- Local brand name: HELICOSOL
- Indication: FOR SOLUTION — ORAL
- Status: approved
FDA
- Status: approved
UREA C 13 in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Other approved in United States
Frequently asked questions
Is UREA C 13 approved in United States?
Yes. FDA authorised it on 17 September 1996; FDA authorised it on 17 December 1999; FDA has authorised it.
Who is the marketing authorisation holder for UREA C 13 in United States?
OTSUKA AMERICA holds the US marketing authorisation.