MedPath
FDA Approval

DEFENCATH

December 21, 2023

HUMAN PRESCRIPTION DRUG LABEL

Taurolidine(40.5 mg in 3 mL)
Heparin(3000 [USP'U] in 3 mL)

Products (2)

DEFENCATH

72990-103

NDA214520

NDA (C73594)

INTRALUMINAL

December 21, 2023

ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSLClass: IACTQuantity: 78.3 mg in 3 mL
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
Code: 8OBZ1M4V3VClass: ACTIBQuantity: 40.5 mg in 3 mL
HeparinActive
Code: T2410KM04AClass: ACTIBQuantity: 3000 [USP'U] in 3 mL

DEFENCATH

72990-105

NDA214520

NDA (C73594)

INTRALUMINAL

December 21, 2023

ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSLClass: IACTQuantity: 130.5 mg in 5 mL
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
Code: 8OBZ1M4V3VClass: ACTIBQuantity: 67.5 mg in 5 mL
HeparinActive
Code: T2410KM04AClass: ACTIBQuantity: 5000 [USP'U] in 5 mL
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