Is Stallergenes FDA approved?

Stallergenes holds 1 FDA-registered establishment in France. 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 Stallergenes's drugs manufactured?

The FDA register lists Antony Cedex. Registered operations: finished drug manufacture.

What drugs does Stallergenes make?

5 products are listed under Stallergenes in the openFDA NDC Directory, most often as tablet, orally disintegrating; kit. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Stallergenes

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

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Registered sites: 1
Active NDC listings: 5
Live patents: 0
Countries: 1
Base: France

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Stallergenes	6 rue Alexis de Tocqueville, Antony Cedex, 92160, France (FRA)	Finished drug manufacture	3004015717266755389

Catalogue

Drug listings by form and route

5 active NDC listings: 5 standardized allergenic. By marketing category: BLA 5.

Dosage form	NDCs
tablet, orally disintegrating	3
kit	2

Route	NDCs
sublingual	3

Labeller name on the listing	NDCs
stallergenes	5

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
Oralair	ANTHOXANTHUM ODORATUM POLLEN, DACTYLIS GLOMERATA POLLEN, LOLIUM PERENNE POLLEN, PHELUM PRATENSE POLLEN, and POA PRATENSIS POLLEN	kit	59617-0020BLA
Oralair	ANTHOXANTHUM ODORATUM POLLEN, DACTYLIS GLOMERATA POLLEN, LOLIUM PERENNE POLLEN, PHELUM PRATENSE POLLEN, and POA PRATENSIS POLLEN	kit	59617-0025BLA
Oralair 100 IR	ANTHOXANTHUM ODORATUM POLLEN, DACTYLIS GLOMERATA POLLEN, LOLIUM PERENNE POLLEN, PHLEUM PRATENSE POLLEN, and POA PRATENSIS POLLEN	tablet, orally disintegrating, sublingual	59617-0010BLA
Oralair 300 IR	ANTHOXANTHUM ODORATUM POLLEN, DACTYLIS GLOMERATA POLLEN, LOLIUM PERENNE POLLEN, PHLEUM PRATENSE POLLEN, and POA PRATENSIS POLLEN	tablet, orally disintegrating, sublingual	59617-0015BLA
Oralair 300 IR	ANTHOXANTHUM ODORATUM POLLEN, DACTYLIS GLOMERATA POLLEN, LOLIUM PERENNE POLLEN, PHLEUM PRATENSE POLLEN, and POA PRATENSIS POLLEN	tablet, orally disintegrating, sublingual	59617-0016BLA

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Enquiry

Common questions

Is Stallergenes FDA approved?: Stallergenes holds 1 FDA-registered establishment in France. 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 Stallergenes's drugs manufactured?: The FDA register lists Antony Cedex. Registered operations: finished drug manufacture.
What drugs does Stallergenes make?: 5 products are listed under Stallergenes in the openFDA NDC Directory, most often as tablet, orally disintegrating; 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.