Register entry
- Registered sites
- 1
- Active NDC listings
- 1
- Live patents
- 10
- Exclusivities
- 1
- Countries
- 1
- Base
- United States
Sites
Registered establishments
1| Establishment | Address | Registered for | FEI / DUNS |
|---|---|---|---|
| Delcath Systems, Inc. | 95 Park Road, Queensbury, New York (NY) 12804, United States (USA) | Finished drug manufacture | 3008822486118956859 |
Exclusivity
Patents and exclusivities
10| Patent | Product | Covers | Expiry |
|---|---|---|---|
| 10098997 | HEPZATOmelphalan hydrochloride | product | Nov 2032 |
| 10369264 | HEPZATOmelphalan hydrochloride | product | Nov 2032 |
| 10569004 | HEPZATOmelphalan hydrochloride | use | Nov 2032 |
| 11241522 | HEPZATOmelphalan hydrochloride | product | Nov 2032 |
| 11633528 | HEPZATOmelphalan hydrochloride | use | Nov 2032 |
| 11083831 | HEPZATOmelphalan hydrochloride | product | Dec 2032 |
| 11833286 | HEPZATOmelphalan hydrochloride | product | Dec 2032 |
| 10195334 | HEPZATOmelphalan hydrochloride | product | Jan 2033 |
| 9314561 | HEPZATOmelphalan hydrochloride | product | Feb 2034 |
| 9707331 | HEPZATOmelphalan hydrochloride | product | Sept 2034 |
| Product | Exclusivity | Until |
|---|---|---|
| HEPZATOMELPHALAN HYDROCHLORIDE | ODE-438 Orphan drug | Aug 2030 |
Catalogue
Marketed products
1| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| Hepzato Kit | melphalan hydrochloride injection, powder, lyophilized, for solution | kit, intra-arterial | 75833-601NDA |
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Enquiry
Common questions
- Is Delcath Systems, Inc. FDA approved?
- Delcath Systems, Inc. holds 1 FDA-registered establishment in the United States. Registration puts a site on the FDA's register and open to inspection; it is not an approval of the company. Approvals attach to individual drug applications.
- Where are Delcath Systems, Inc.'s drugs manufactured?
- The FDA register lists Queensbury, NY. Registered operations: finished drug manufacture.
- What drugs does Delcath Systems, Inc. make?
- 1 product is listed under Delcath Systems, Inc. in the openFDA NDC Directory, most often as kit. The full breakdown by dosage form and route is above. A listing count is not a sales figure.
Compiled from FDA establishment registrations, the openFDA NDC Directory, the Orange Book and the FDA drug shortage database. Not claimed by the company. Sources and methodology.