Is Fonseca Biosciences, LLC FDA approved?

Fonseca Biosciences, LLC holds no registered establishment of its own; 1 drug product is listed under its name in the National Drug Code Directory, made at sites registered to other firms.

What drugs does Fonseca Biosciences, LLC make?

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

Fonseca Biosciences, LLC

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

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Registered sites: 0
Active NDC listings: 1
Live patents: 4
Countries: 0

Exclusivity

Patents and exclusivities

Patent	Product	Covers	Expiry
9119859	XTOROfinafloxacin	use	Jul 2030
9993483	XTOROfinafloxacin	product	Jul 2030
8536167	XTOROfinafloxacin	use	Aug 2031
9504691	XTOROfinafloxacin	product	Nov 2033

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
XTORO	finafloxacin	suspension, auricular (otic)	83709-001NDA

Enquiry

Common questions

Is Fonseca Biosciences, LLC FDA approved?: Fonseca Biosciences, LLC holds no registered establishment of its own; 1 drug product is listed under its name in the National Drug Code Directory, made at sites registered to other firms.
What drugs does Fonseca Biosciences, LLC make?: 1 product is listed under Fonseca Biosciences, LLC in the openFDA NDC Directory, most often as suspension. 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.