Is The University of Texas Southwestern Medical Center FDA approved?

The University of Texas Southwestern Medical Center 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 The University of Texas Southwestern Medical Center's registered sites?

The FDA register lists Dallas, TX. Registered operations: analytical testing, labelling, packaging, positron emission tomography drug production.

What drugs does The University of Texas Southwestern Medical Center make?

1 product is listed under The University of Texas Southwestern Medical Center in the openFDA NDC Directory, most often as injection, solution. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

The University of Texas Southwestern Medical Center

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

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Registered sites: 1
Active NDC listings: 1
Live patents: 0
Countries: 1
Base: United States

Authorisation

Registered operations

Analytical testing1Labelling1Packaging1positron emission tomography drug production1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
The University of Texas Southwestern Medical Center	5323 Harry Hines Blvd, Dallas, Texas (TX) 75390, United States (USA)	Analytical testing, Labelling, Packaging, positron emission tomography drug production	3012367823800771545

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
Ammonia N 13	AMMONIA N-13	injection, solution, intravenous	70681-001ANDA

Neighbours

Registered in the same town

Eisinger Smith LLCDallas, TX · 2 sites
PETNET Solutions, Inc.DALLAS, TX
Cardinal Health 418, Inc.Dallas, TX
SOFIE Co. dba SOFIEDallas, TX
Univar Solutions USA LLCDallas, TX
Reed Baileydallas, TX
Dhaliwal Pharmaceuticals Laboratories LLCDallas, TX
Aloe Vera Of America IncDallas, TX
Bond Pharmacy INCDallas, TX
Gleeco Labs LLCDallas, TX
MEDWISE LIFESCIENCES INC.Dallas, TX
McKinley Resources Inc.Dallas, TX

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Enquiry

Common questions

Is The University of Texas Southwestern Medical Center FDA approved?: The University of Texas Southwestern Medical Center 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 The University of Texas Southwestern Medical Center's registered sites?: The FDA register lists Dallas, TX. Registered operations: analytical testing, labelling, packaging, positron emission tomography drug production.
What drugs does The University of Texas Southwestern Medical Center make?: 1 product is listed under The University of Texas Southwestern Medical Center in the openFDA NDC Directory, most often as injection, solution. 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.