Register entry
Aucta Pharmaceuticals, Inc.
- Registered sites
- 2
- Drug products
- 8
- Live patents
- 9
- 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 |
|---|---|---|---|
| Aucta Pharmaceuticals, Inc. | Basking Ridge, NJUnited States | Analytical testing | 3029416323 |
| Aucta Pharmaceuticals, Inc. | Piscataway, NJUnited States | Analytical testing, Labelling, Finished drug manufacture, Packaging | 3015204529 |
Exclusivity
Patents
9Unexpired Orange Book patents where this company is the application holder.
| Product | Active ingredient | Expiry |
|---|---|---|
| MOTPOLY XR | LACOSAMIDE | Jun 2040 |
Catalogue
Marketed products
8Showing 8 of 8.
| Brand | Generic name | Form | Category |
|---|---|---|---|
| Arformoterol Tartrate Inhalation Solution | Arformoterol Tartrate | SOLUTION | ANDA |
| Fosfomycin Tromethamine | Fosfomycin tromethamine | GRANULE, FOR SOLUTION | ANDA |
| MOTPOLY XR | lacosamide | CAPSULE, EXTENDED RELEASE | NDA |
| MOTPOLY XR | lacosamide | CAPSULE, EXTENDED RELEASE | NDA |
| MOTPOLY XR | lacosamide | CAPSULE, EXTENDED RELEASE | NDA |
| PYQUVI | deflazacort | SUSPENSION | ANDA |
| ZELVYSIA | SAPROPTERIN DIHYDROCHLORIDE | POWDER, FOR SOLUTION | ANDA |
| ZELVYSIA | sapropterin dihydrochloride | POWDER, FOR SOLUTION | 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.