Is Cosette Pharmaceuticals NC Laboratories, LLC FDA approved?

Cosette Pharmaceuticals NC Laboratories, 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 Cosette Pharmaceuticals NC Laboratories, LLC's drugs manufactured?

The FDA register lists Lincolnton, NC. Registered operations: analytical testing, labelling, finished drug manufacture, packaging.

What drugs does Cosette Pharmaceuticals NC Laboratories, LLC make?

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

Cosette Pharmaceuticals NC Laboratories, 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

Authorisation

Registered operations

Analytical testing1Labelling1Finished drug manufacture1Packaging1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Cosette Pharmaceuticals NC Laboratories, LLC	1877 Kawai Road, Lincolnton, North Carolina (NC) 28092, United States (USA)	Analytical testing, Labelling, Finished drug manufacture, Packaging	1053439079419931

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
Clomiphene Citrate	Clomiphene Citrate	tablet, oral	83390-107ANDA

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Enquiry

Common questions

Is Cosette Pharmaceuticals NC Laboratories, LLC FDA approved?: Cosette Pharmaceuticals NC Laboratories, 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 Cosette Pharmaceuticals NC Laboratories, LLC's drugs manufactured?: The FDA register lists Lincolnton, NC. Registered operations: analytical testing, labelling, finished drug manufacture, packaging.
What drugs does Cosette Pharmaceuticals NC Laboratories, LLC make?: 1 product is listed under Cosette Pharmaceuticals NC Laboratories, LLC in the openFDA NDC Directory, most often as tablet. 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.