Register entry
Aquestive Therapeutics
- Registered sites
- 1
- Drug products
- 6
- Live patents
- 4
- 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 testingdistributeLabellingFinished drug manufacturePackagingRelabellingRepackaging
Sites
Facilities
1| Site | Location | Operations | FEI |
|---|---|---|---|
| Aquestive Therapeutics | Portage, INUnited States | Analytical testing, distribute, Labelling, Finished drug manufacture, Packaging, Relabelling, Repackaging | 3004395604 |
Exclusivity
Patents
4Unexpired Orange Book patents where this company is the application holder.
| Product | Active ingredient | Expiry |
|---|---|---|
| ZUPLENZ | ONDANSETRON | Nov 2029 |
| ZUPLENZ | ONDANSETRON | Jul 2030 |
Catalogue
Marketed products
6Showing 6 of 6.
| Brand | Generic name | Form | Category |
|---|---|---|---|
| - | Riluzole Oral | FILM | EXPORT ONLY |
| SYMPAZAN | clobazam | FILM | NDA |
| SYMPAZAN | clobazam | FILM | NDA |
| SYMPAZAN | clobazam | FILM | NDA |
| - | ondansetron oral | FILM | EXPORT ONLY |
| - | ondansetron oral film | FILM | EXPORT ONLY |
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.