Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 214520
Company: CORMEDIX

Products on NDA 214520

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DEFENCATH	HEPARIN SODIUM; TAUROLIDINE	3,000 UNITS/3ML (1,000 UNITS/ML);40.5MG/3ML (13.5MG/ML)	SOLUTION;N/A	Prescription	None	Yes	Yes
DEFENCATH	HEPARIN SODIUM; TAUROLIDINE	5,000 UNITS/5ML (1,000 UNITS/ML);67.5MG/5ML (13.5MG/ML)	SOLUTION;N/A	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 214520

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/15/2023	ORIG-1	Approval	Type 1 - New Molecular Entity and Type 4 - New Combination	PRIORITY	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/214520Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/214520Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/214520Orig1s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/19/2024	SUPPL-3	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/214520s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/214520Orig1s003ltr.pdf

Labels for NDA 214520

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/19/2024	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/214520s003lbl.pdf
11/15/2023	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/214520Orig1s000lbl.pdf