Is Photocure Inc. FDA approved?

Photocure Inc. 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 Photocure Inc. make?

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

Photocure Inc.

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

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Registered sites: 0
Active NDC listings: 1
Live patents: 3
Countries: 0

Exclusivity

Patents and exclusivities

Patent	Product	Covers	Expiry
10556010	CYSVIEW KIThexaminolevulinate hydrochloride	use	Dec 2036
11311620	CYSVIEW KIThexaminolevulinate hydrochloride	use	Dec 2036
11235168	CYSVIEW KIThexaminolevulinate hydrochloride	use	Jan 2038

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
Cysview	Hexaminolevulinate hydrochloride	kit	10511-3001NDA

Enquiry

Common questions

Is Photocure Inc. FDA approved?: Photocure Inc. 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 Photocure Inc. make?: 1 product is listed under Photocure Inc. in the openFDA NDC Directory, most often as kit. 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.