Register entryRepackager / relabeller
- Registered sites
- 1
- Active NDC listings
- 0
- Live patents
- 2
- Countries
- 1
- Base
- United States
Sites
Registered establishments
1| Establishment | Address | Registered for | FEI / DUNS |
|---|---|---|---|
| Fidelity BioPharma Co. | 157 Church Street, Fl 19, New Haven, Connecticut (CT) 06510, United States (USA) | Labelling | 3017213802111372206 |
Exclusivity
Patents and exclusivities
2| Patent | Product | Covers | Expiry |
|---|---|---|---|
| 12042484 | ONTRALFYtizanidine hydrochloride | product | May 2042 |
| 12263158 | ONTRALFYtizanidine hydrochloride | product | May 2042 |
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Enquiry
Common questions
- Is Fidelity BioPharma Co. FDA approved?
- Fidelity BioPharma Co. 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 Fidelity BioPharma Co.'s registered sites?
- The FDA register lists New Haven, CT. Registered operations: labelling.
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.