An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 219908
Company: CELCUITY INC..

Products on NDA 219908

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
REVTORPYK	GEDATOLISIB	180MG	VIAL;SINGLE-DOSE	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 219908

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/14/2026	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/219908Orig1s000ltr.pdf

Top