Register entry
Delcath Systems, Inc.
- Registered sites
- 1
- Drug products
- 1
- Live patents
- 10
- Countries
- 1
- Base
- United States
Authorisation
Registered operations
What the FDA has registered these sites to do. This is the regulatory record, not a marketing claim.
Finished drug manufacture
Sites
Facilities
1| Site | Location | Operations | FEI |
|---|---|---|---|
| Delcath Systems, Inc. | Queensbury, NYUnited States | Finished drug manufacture | 3008822486 |
Exclusivity
Patents
10Unexpired Orange Book patents where this company is the application holder.
| Product | Active ingredient | Expiry |
|---|---|---|
| HEPZATO | MELPHALAN HYDROCHLORIDE | Nov 2032 |
| HEPZATO | MELPHALAN HYDROCHLORIDE | Dec 2032 |
| HEPZATO | MELPHALAN HYDROCHLORIDE | Jan 2033 |
| HEPZATO | MELPHALAN HYDROCHLORIDE | Feb 2034 |
| HEPZATO | MELPHALAN HYDROCHLORIDE | Sept 2034 |
Catalogue
Marketed products
1Showing 1 of 1.
| Brand | Generic name | Form | Category |
|---|---|---|---|
| Hepzato Kit | melphalan hydrochloride injection, powder, lyophilized, for solution | KIT | NDA |
Provenance
Facility and operations data from the FDA Drug Establishments Current Registration Site. Product data from the openFDA National Drug Code Directory. Patent and exclusivity data from the FDA Orange Book. Shortage data from the FDA drug shortage database. Contact details the FDA publishes for registered establishments are deliberately not reproduced here. This entry is compiled from public records and has not been claimed by the company.