Is Celcuity Inc. FDA approved?

Celcuity Inc. holds no registered establishment of its own; 2 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.

What drugs does Celcuity Inc. make?

2 products are listed under Celcuity Inc. in the openFDA NDC Directory, most often as injection, powder, for solution; powder. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Celcuity Inc.

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

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Registered sites: 0
Active NDC listings: 2
Labeller names: 2
Live patents: 0
Countries: 0

Catalogue

Drug listings by form and route

2 active NDC listings: 1 bulk ingredient, 1 human prescription drug. By marketing category: BULK INGREDIENT 1, NDA 1.

Dosage form	NDCs
injection, powder, for solution	1
powder	1

Route	NDCs
intravenous	1

Labeller name on the listing	NDCs
celcuity	1
celcuity inc.	1

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
-	Gedatolisib	powder	84577-750BULK INGREDIENT
REVTORPYK	gedatolisib	injection, powder, for solution, intravenous	84577-751NDA

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Common questions

Is Celcuity Inc. FDA approved?: Celcuity Inc. holds no registered establishment of its own; 2 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.
What drugs does Celcuity Inc. make?: 2 products are listed under Celcuity Inc. in the openFDA NDC Directory, most often as injection, powder, for solution; powder. 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.