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FDA NDA · NDA214520

DEFENCATH

taurolidine and heparin

Sponsor: CORMEDIX

APPLICATION
NDA214520
TYPE
NDA
ORIGINAL APPROVAL
2023-11-15
LATEST ACTION
2024-12-19
ROUTE
INTRALUMINAL, N/A
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

DEFENCATH · ReferencePrescription
HEPARIN SODIUM 5,000 UNITS/5ML (1,000 UNITS/ML), TAUROLIDINE 67.5MG/5ML (13.5MG/ML) · SOLUTION · N/A
DEFENCATH · ReferencePrescription
HEPARIN SODIUM 3,000 UNITS/3ML (1,000 UNITS/ML), TAUROLIDINE 40.5MG/3ML (13.5MG/ML) · SOLUTION · N/A

Approval history

2024-12-19Labeling · Supplement 3 · standard — Letter ↗AP
2023-11-15Type 1 - New Molecular Entity and Type 4 - New Combination · Original · priority — Label ↗AP
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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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