Is Fougera Pharmaceuticals, LLC FDA approved?

Fougera Pharmaceuticals, LLC holds 2 FDA-registered establishments 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 Fougera Pharmaceuticals, LLC's drugs manufactured?

The FDA register lists Hicksville, NY; Melville, NY. Registered operations: analytical testing, labelling, finished drug manufacture, packaging.

What drugs does Fougera Pharmaceuticals, LLC make?

6 products are listed under Fougera Pharmaceuticals, LLC in the openFDA NDC Directory, most often as cream; solution; lotion. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Fougera Pharmaceuticals, LLC

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

Request a quote Claim this profile

Registered sites: 2
Active NDC listings: 6
Labeller names: 2
Live patents: 0
Countries: 1
Base: United States

Authorisation

Registered operations

Analytical testing1Labelling1Finished drug manufacture1Packaging1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Fougera Pharmaceuticals, LLC	55 Cantiague Rock Road, Hicksville, New York (NY) 11801, United States (USA)	Labelling, Finished drug manufacture, Packaging	2410271174491316
Fougera Pharmaceuticals, LLC	60 Baylis Road, Melville, New York (NY) 11747, United States (USA)	Analytical testing	2432435043838424

Catalogue

Drug listings by form and route

6 active NDC listings: 5 human prescription drug, 1 human otc drug. By marketing category: ANDA 5, OTC MONOGRAPH DRUG 1.

Dosage form	NDCs
cream	2
solution	2
lotion	1
ointment	1

Route	NDCs
topical	5
auricular (otic)	1

Labeller name on the listing	NDCs
fougera pharmaceuticals, llc	5
fougera pharmaceuticals inc.	1

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
Amcinonide	Amcinonide	cream, topical	0168-0278ANDA
Fluocinolone Acetonide	fluocinolone acetonide	solution, topical	0168-0059ANDA
Lidocaine	Lidocaine	ointment, topical	0168-0204ANDA
Metronidazole	Metronidazole	cream, topical	0168-0323ANDA
Metronidazole	Metronidazole	lotion, topical	0168-0383ANDA
Swim-EAR	Swim-EAR	solution, auricular (otic)	0168-0126OTC MONOGRAPH DRUG

Neighbours

Registered in the same town

Certified Laboratories, LLCMelville, NY
Kedrion Biopharma Inc.Melville, NY
Apothecus Pharmaceutical Corp.HICKSVILLE, NY

Compare

Comparable companies in United States

Deseret Laboratories Incorporated2 sites · 858 NDC
Padagis Israel Pharmaceuticals Ltd2 sites · 236 NDC
PureTek Corporation2 sites · 178 NDC
Cosmax Usa Corporation2 sites · 142 NDC
Apotheca Company2 sites · 110 NDC
Nivagen Pharmaceuticals LLC2 sites · 106 NDC
GOJO Industries, LLC2 sites · 84 NDC
KVK-TECH, INC.2 sites · 71 NDC
Revlon Consumer Products Corporation2 sites · 61 NDC
Samsung Biologics Co., Ltd.2 sites · 57 NDC

Enquiry

Common questions

Is Fougera Pharmaceuticals, LLC FDA approved?: Fougera Pharmaceuticals, LLC holds 2 FDA-registered establishments 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 Fougera Pharmaceuticals, LLC's drugs manufactured?: The FDA register lists Hicksville, NY; Melville, NY. Registered operations: analytical testing, labelling, finished drug manufacture, packaging.
What drugs does Fougera Pharmaceuticals, LLC make?: 6 products are listed under Fougera Pharmaceuticals, LLC in the openFDA NDC Directory, most often as cream; solution; lotion. 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.