Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 214520
Company: CORMEDIX
Company: CORMEDIX
| 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 |
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.cfm |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 11/15/2023 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/214520Orig1s000lbl.pdf |