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General MedicationsN/AStandard

DEFENCATH

HEPARIN SODIUM; TAUROLIDINE

Standard Dose
5,000 UNITS/5ML (1,000 UNITS/ML);67.5MG/5ML (13.5MG/ML)
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview DEFENCATH is listed in Drugs@FDA under application 214520 (NDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient HEPARIN SODIUM; TAUROLIDINE Form and strength SOLUTION;N/A - 5,000 UNITS/5ML (1,000 UNITS/ML);67.5MG/5ML (13.5MG/ML) Sponsor CORMEDIX Submission history Latest submission status date: 2024-12-19 00:00:00.

Structured Monograph

Clinical summary

Approval overview DEFENCATH is listed in Drugs@FDA under application 214520 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient HEPARIN SODIUM; TAUROLIDINE Form and strength SOLUTION;N/A - 5,000 UNITS/5ML (1,000 UNITS/ML);67.5MG/5ML (13.5MG/ML) Sponsor CORMEDIX Submission history Latest submission status date: 2024-12-19 00:00:00. Submission type: SUPPL.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.