Is CSL Behring Lengnau AG FDA approved?

CSL Behring Lengnau AG holds no registered establishment of its own; 12 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.

What drugs does CSL Behring Lengnau AG make?

12 products are listed under CSL Behring Lengnau AG 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.

CSL Behring Lengnau AG

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

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Registered sites: 0
Active NDC listings: 12
Live patents: 0
Countries: 0

Catalogue

Drug listings by form and route

12 active NDC listings: 12 plasma derivative. By marketing category: BLA 12.

Dosage form	NDCs
kit	12

Route	NDCs

Labeller name on the listing	NDCs
csl behring lengnau ag	12

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
AFSTYLA Antihemophilic Factor (Recombinant), Single Chain	ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT	kit	69911-474BLA
AFSTYLA Antihemophilic Factor (Recombinant), Single Chain	ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT	kit	69911-475BLA
AFSTYLA Antihemophilic Factor (Recombinant), Single Chain	ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT	kit	69911-476BLA
AFSTYLA Antihemophilic Factor (Recombinant), Single Chain	ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT	kit	69911-477BLA
AFSTYLA Antihemophilic Factor (Recombinant), Single Chain	ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT	kit	69911-478BLA
AFSTYLA Antihemophilic Factor (Recombinant), Single Chain	ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT	kit	69911-480BLA
AFSTYLA Antihemophilic Factor (Recombinant), Single Chain	ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT	kit	69911-481BLA
IDELVION	Coagulation Factor IX Recombinant Human	kit	69911-864BLA
IDELVION	Coagulation Factor IX Recombinant Human	kit	69911-865BLA
IDELVION	Coagulation Factor IX Recombinant Human	kit	69911-866BLA
IDELVION	Coagulation Factor IX Recombinant Human	kit	69911-867BLA
IDELVION	Coagulation Factor IX Recombinant Human	kit	69911-869BLA

Enquiry

Common questions

Is CSL Behring Lengnau AG FDA approved?: CSL Behring Lengnau AG holds no registered establishment of its own; 12 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.
What drugs does CSL Behring Lengnau AG make?: 12 products are listed under CSL Behring Lengnau AG 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.