Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 214520

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DEFENCATH (HEPARIN SODIUM; TAUROLIDINE)
3,000 UNITS/3ML (1,000 UNITS/ML);40.5MG/3ML (13.5MG/ML)
Marketing Status: Prescription

Active Ingredient: HEPARIN SODIUM; TAUROLIDINE
Proprietary Name: DEFENCATH
Dosage Form; Route of Administration: SOLUTION; N/A
Strength: 3,000 UNITS/3ML (1,000 UNITS/ML);40.5MG/3ML (13.5MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N214520
Product Number: 001
Approval Date: Nov 15, 2023
Applicant Holder Full Name: CORMEDIX INC
Marketing Status:  Prescription
Patent and Exclusivity Information

DEFENCATH (HEPARIN SODIUM; TAUROLIDINE)
5,000 UNITS/5ML (1,000 UNITS/ML);67.5MG/5ML (13.5MG/ML)
Marketing Status: Prescription

Active Ingredient: HEPARIN SODIUM; TAUROLIDINE
Proprietary Name: DEFENCATH
Dosage Form; Route of Administration: SOLUTION; N/A
Strength: 5,000 UNITS/5ML (1,000 UNITS/ML);67.5MG/5ML (13.5MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N214520
Product Number: 002
Approval Date: Nov 15, 2023
Applicant Holder Full Name: CORMEDIX INC
Marketing Status:  Prescription
Patent and Exclusivity Information