FDA Approval for HEPZATO KIT issued to DELCATH SYSTEMS INC
$DCTH
Medical/Dental Instruments
Health Care
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 KIT | MELPHALAN HYDROCHLORIDE | 50MG | INJECTABLE;INJECTION | 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 |
|---|---|---|---|---|---|---|---|
| 08/14/2023 | ORIG-1 | Approval | Type 4 - New Combination | PRIORITY |
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