Register entry
Tris Pharma, Inc.
- Registered sites
- 2
- Drug products
- 20
- Live patents
- 32
- 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.
Analytical testingLabellingFinished drug manufacturePackaging
Sites
Facilities
2| Site | Location | Operations | FEI |
|---|---|---|---|
| Tris Pharma, Inc. | Cranbury, NJUnited States | Finished drug manufacture | 3008079002 |
| Tris Pharma Inc | Monmouth Junction, NJUnited States | Analytical testing, Labelling, Finished drug manufacture, Packaging | 3004712471 |
Exclusivity
Patents
32Unexpired Orange Book patents where this company is the application holder.
| Product | Active ingredient | Expiry |
|---|---|---|
| DYANAVEL XR | AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE | Mar 2027 |
| DYANAVEL XR | AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE | Mar 2029 |
| DYANAVEL XR | AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE | Sept 2036 |
| DYANAVEL XR 10 | AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE | Mar 2027 |
| DYANAVEL XR 10 | AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE | Sept 2038 |
| DYANAVEL XR 10 | AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE | Feb 2040 |
| DYANAVEL XR 15 | AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE | Mar 2027 |
| DYANAVEL XR 15 | AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE | Sept 2038 |
| DYANAVEL XR 15 | AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE | Feb 2040 |
| DYANAVEL XR 20 | AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE | Mar 2027 |
| DYANAVEL XR 20 | AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE | Sept 2038 |
| DYANAVEL XR 20 | AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE | Feb 2040 |
| DYANAVEL XR 5 | AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE | Mar 2027 |
| DYANAVEL XR 5 | AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE | Sept 2038 |
| DYANAVEL XR 5 | AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE | Feb 2040 |
| ONYDA XR | CLONIDINE HYDROCHLORIDE | Mar 2029 |
| ONYDA XR | CLONIDINE HYDROCHLORIDE | Jul 2041 |
| TUZISTRA XR | CHLORPHENIRAMINE POLISTIREX; CODEINE POLISTIREX | Mar 2027 |
| TUZISTRA XR | CHLORPHENIRAMINE POLISTIREX; CODEINE POLISTIREX | Mar 2029 |
Catalogue
Marketed products
20Showing 20 of 20.
| Brand | Generic name | Form | Category |
|---|---|---|---|
| Cyproheptadine Hydrochloride | Cyproheptadine Hydrochloride | SYRUP | ANDA |
| Febuxostat | febuxostat | TABLET | ANDA |
| Febuxostat | febuxostat | TABLET | ANDA |
| Lacosamide | Lacosamide | TABLET | ANDA |
| Lacosamide | Lacosamide | TABLET | ANDA |
| Lacosamide | Lacosamide | TABLET | ANDA |
| Lacosamide | Lacosamide | TABLET | ANDA |
| Paliperidone | paliperidone | TABLET, EXTENDED RELEASE | ANDA |
| Paliperidone | paliperidone | TABLET, EXTENDED RELEASE | ANDA |
| Paliperidone | paliperidone | TABLET, EXTENDED RELEASE | ANDA |
| Paliperidone | paliperidone | TABLET, EXTENDED RELEASE | ANDA |
| Potassium Chloride | Potassium Chloride | SOLUTION | ANDA |
| Potassium Chloride | Potassium Chloride | SOLUTION | ANDA |
| Pregabalin | Pregabalin | CAPSULE | ANDA |
| Pregabalin | Pregabalin | CAPSULE | ANDA |
| Pregabalin | Pregabalin | CAPSULE | ANDA |
| Pregabalin | Pregabalin | CAPSULE | ANDA |
| Pregabalin | Pregabalin | CAPSULE | ANDA |
| Pregabalin | Pregabalin | CAPSULE | ANDA |
| Pregabalin | Pregabalin | CAPSULE | ANDA |
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.