Is Aquestive Therapeutics FDA approved?

Aquestive Therapeutics 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 Aquestive Therapeutics's drugs manufactured?

The FDA register lists Portage, IN. Registered operations: analytical testing, distribute, labelling, finished drug manufacture, packaging, relabelling, repackaging.

What drugs does Aquestive Therapeutics make?

6 products are listed under Aquestive Therapeutics in the openFDA NDC Directory, most often as film. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Aquestive Therapeutics

Data as of 24 Sept 2026 · How to read this entry

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Registered sites: 1
Active NDC listings: 6
Live patents: 4
Countries: 1
Base: United States

Authorisation

Registered operations

Analytical testing1distribute1Labelling1Finished drug manufacture1Packaging1Relabelling1Repackaging1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Aquestive Therapeutics	6465 Ameriplex Drive, Portage, Indiana (IN) 46368, United States (USA)	Analytical testing, distribute, Labelling, Finished drug manufacture, Packaging, Relabelling, Repackaging	3004395604079269181

Catalogue

Drug listings by form and route

6 active NDC listings: 3 drug for further processing, 3 human prescription drug. By marketing category: EXPORT ONLY 3, NDA 3.

Dosage form	NDCs
film	6

Route	NDCs
oral	3

Labeller name on the listing	NDCs
aquestive therapeutics	6

Exclusivity

Patents and exclusivities

Patent	Product	Covers	Expiry
8580830	ZUPLENZondansetron	product	Nov 2029
9095577	ZUPLENZondansetron	product	Jul 2030

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
-	Riluzole Oral	film	10094-355EXPORT ONLY
SYMPAZAN	clobazam	film, oral	10094-205NDA
SYMPAZAN	clobazam	film, oral	10094-210NDA
SYMPAZAN	clobazam	film, oral	10094-220NDA
-	ondansetron oral	film	10094-604EXPORT ONLY
-	ondansetron oral film	film	10094-608EXPORT ONLY

Neighbours

Registered in the same town

MSI Express IncPortage, IN

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Enquiry

Common questions

Is Aquestive Therapeutics FDA approved?: Aquestive Therapeutics 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 Aquestive Therapeutics's drugs manufactured?: The FDA register lists Portage, IN. Registered operations: analytical testing, distribute, labelling, finished drug manufacture, packaging, relabelling, repackaging.
What drugs does Aquestive Therapeutics make?: 6 products are listed under Aquestive Therapeutics in the openFDA NDC Directory, most often as film. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

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.