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General MedicationsORALStandard

IDKIT:HP

CITRIC ACID; UREA C-13

Standard Dose
4GM;75MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview IDKIT:HP is listed in Drugs@FDA under application 021314 (NDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient CITRIC ACID; UREA C-13 Form and strength FOR SOLUTION, TABLET, FOR SOLUTION;ORAL - 4GM;75MG Sponsor MERIDIAN BIOSCIENCE Submission history Latest submission status date: 2016-07-25 00:00:00.

Structured Monograph

Clinical summary

Approval overview IDKIT:HP is listed in Drugs@FDA under application 021314 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient CITRIC ACID; UREA C-13 Form and strength FOR SOLUTION, TABLET, FOR SOLUTION;ORAL - 4GM;75MG Sponsor MERIDIAN BIOSCIENCE Submission history Latest submission status date: 2016-07-25 00:00:00. Submission type: SUPPL.

Monitoring

  • • Marketing status: Prescription
  • • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.