FDA Approval for DEFENCATH issued to CORMEDIX INC
$CRMD
Biotechnology: Pharmaceutical Preparations
Health Care
New Drug Application (NDA): 214520
Company: CORMEDIX INC
Company: CORMEDIX INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DEFENCATH | TAUROLIDINE AND HEPARIN SODIUM | SOLUTION;CATHETER LOCK | Prescription | None | No | No |
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)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/214520s000lbl.pdf |
| 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/2023/214520s000lbl.pdf |