Register entryRepackager / relabeller
Stealth Biotherapeutics Inc.
- Registered sites
- 1
- Drug products
- 1
- Live patents
- 6
- 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.
Labelling
Sites
Facilities
1| Site | Location | Operations | FEI |
|---|---|---|---|
| Stealth BioTherapeutics Inc. | Needham, MAUnited States | Labelling | 3030795113 |
Exclusivity
Patents
6Unexpired Orange Book patents where this company is the application holder.
| Product | Active ingredient | Expiry |
|---|---|---|
| FORZINITY | ELAMIPRETIDE HYDROCHLORIDE | Jan 2027 |
| FORZINITY | ELAMIPRETIDE HYDROCHLORIDE | Feb 2034 |
Catalogue
Marketed products
1Showing 1 of 1.
| Brand | Generic name | Form | Category |
|---|---|---|---|
| FORZINITY | Elamipretide Hydrochloride | INJECTION | 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.