Register entry

Filltech USA, LLC

Data as of · How to read this entry

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

Registered operations

Finished drug manufacture1Relabelling1Repackaging1
Sites

Registered establishments

1
EstablishmentAddressRegistered forFEI / DUNS
Filltech USA, LLC380 Palmer Rd, Rockwell, North Carolina (NC) 28138, United States (USA)Finished drug manufacture, Relabelling, Repackaging1000512200926433855
Catalogue

Marketed products

1
BrandGeneric nameForm / routeNDC
Sonacaine Topical Anesthetic With MentholLIDOCAINEgel, topical62221-935OTC MONOGRAPH DRUG
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Common questions

Is Filltech USA, LLC FDA approved?
Filltech USA, 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 Filltech USA, LLC's drugs manufactured?
The FDA register lists Rockwell, NC. Registered operations: finished drug manufacture, relabelling, repackaging.
What drugs does Filltech USA, LLC make?
1 product is listed under Filltech USA, LLC in the openFDA NDC Directory, most often as gel. 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.