New Drug Application (NDA): 201848
Company: DELCATH SYSTEMS INC
Company: DELCATH SYSTEMS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| HEPZATO | MELPHALAN HYDROCHLORIDE | EQ 50MG BASE/VIAL | POWDER;INTRA-ARTERIAL | 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 |
|---|---|---|---|---|---|---|---|
| 08/14/2023 | ORIG-1 | Approval | Type 4 - New Combination | STANDARD; Orphan |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/201848s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/201848Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/201848Orig1s000TOC.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/01/2024 | SUPPL-7 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 07/10/2024 | SUPPL-5 | Manufacturing (CMC)-Manufacturing Process |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/201848Orig1s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/201848Orig1s005ltr.pdf | |
| 01/22/2024 | SUPPL-4 | REMS - MODIFIED - D-N-A |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/201848Orig1s004Correctedltr.pdf |
| 05/22/2024 | SUPPL-3 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/201848Orig1s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/201848Orig1s003ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 07/10/2024 | SUPPL-5 | Manufacturing (CMC)-Manufacturing Process | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/201848Orig1s005lbl.pdf | |
| 05/22/2024 | SUPPL-3 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/201848Orig1s003lbl.pdf | |
| 08/14/2023 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/201848s000lbl.pdf |