Is pNeo LLC FDA approved?

pNeo LLC 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 pNeo LLC's drugs manufactured?

The FDA register lists Denton, TX. Registered operations: finished drug manufacture.

What drugs does pNeo LLC make?

1 product is listed under pNeo LLC in the openFDA NDC Directory, most often as liquid. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

pNeo LLC

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

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
pNeo LLC	204 Cardinal Drive, Denton, Texas (TX) 76209, United States (USA)	Finished drug manufacture	3011418975828917653

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
Shusher Care	ISOTONIC SODIUM CHLORIDE	liquid, respiratory (inhalation)	85471-001UNAPPROVED DRUG OTHER

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Enquiry

Common questions

Is pNeo LLC FDA approved?: pNeo LLC 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 pNeo LLC's drugs manufactured?: The FDA register lists Denton, TX. Registered operations: finished drug manufacture.
What drugs does pNeo LLC make?: 1 product is listed under pNeo LLC in the openFDA NDC Directory, most often as liquid. 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.