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General MedicationsORALGeneric

PYLORI-CHEK BREATH TEST

UREA C-13

Standard Dose
100MG/VIAL
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Discontinued
Summary

Approval overview PYLORI-CHEK BREATH TEST is listed in Drugs@FDA under application 020900 (NDA).

Review priority: STANDARD Marketing status: Discontinued Active ingredient UREA C-13 Form and strength FOR SOLUTION;ORAL - 100MG/VIAL Sponsor DXS DEVICES Submission history Latest submission status date: 1999-02-04 00:00:00.

Structured Monograph

Clinical summary

Approval overview PYLORI-CHEK BREATH TEST is listed in Drugs@FDA under application 020900 (NDA). Review priority: STANDARD Marketing status: Discontinued Active ingredient UREA C-13 Form and strength FOR SOLUTION;ORAL - 100MG/VIAL Sponsor DXS DEVICES Submission history Latest submission status date: 1999-02-04 00:00:00. Submission type: ORIG.

Monitoring

  • • Marketing status: Discontinued
  • • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.