Is Orchard Therapeutics (Europe) Ltd FDA approved?

Orchard Therapeutics (Europe) Ltd 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 Orchard Therapeutics (Europe) Ltd make?

1 product is listed under Orchard Therapeutics (Europe) Ltd 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.

Orchard Therapeutics (Europe) Ltd

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

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

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Marketed products

Brand	Generic name	Form / route	NDC
LENMELDY	atidarsagene autotemcel	suspension, intravenous	83222-0200BLA

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Common questions

Is Orchard Therapeutics (Europe) Ltd FDA approved?: Orchard Therapeutics (Europe) Ltd 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 Orchard Therapeutics (Europe) Ltd make?: 1 product is listed under Orchard Therapeutics (Europe) Ltd 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.