ACTIVE SUBSTANCE / INN

UREA C-13

Brand name(s): BREATHTEK UBT FOR H-PYLORI, PYLORI-CHEK BREATH TEST, MERETEK UBT KIT (W/ PRANACTIN), IDKIT:HP, HELICOSOL
FDA LISTED
PRESCRIPTION
DISCONTINUED
NDA020900
NDA020586
ACTIVE SUBSTANCE
Urea C-13
REGULATORS
FDA
SPONSORS / MAH
DXS DEVICES, MERIDIAN BIOSCIENCE, OTSUKA AMERICA
TOTAL APPLICATIONS
5
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
HELICOSOLNDA021092METABOLIC SOLUTIONSDiscontinued
PYLORI-CHEK BREATH TESTNDA020900DXS DEVICESDiscontinued
IDKIT:HPNDA021314MERIDIAN BIOSCIENCEPrescription
MERETEK UBT KIT (W/ PRANACTIN)NDA020586OTSUKA AMERICADiscontinued
BREATHTEK UBT FOR H-PYLORINDA020586OTSUKA AMERICADiscontinued

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