REVTORPYK
NDA 219908 · New Drug Application (NDA) Prescription
GEDATOLISIB
- Sponsor (Drugs@FDA)
- CELCUITY Company: Celcuity Inc. (CELC)
- First approved
- Latest action
Drugs on HealthTrade
Drugs whose FDA actions or confirmed applications cite this number. A drug listed from this record shows “Not yet reviewed” on its page until an editor checks it.
Products
| Product | Name and ingredient | Form and strength | Marketing status | TE code | Reference | Orange Book |
|---|---|---|---|---|---|---|
| 001 | REVTORPYK GEDATOLISIB | POWDER;INTRAVENOUS 180MG/VIAL | Prescription | – | Reference listed drug, Reference standard | RXApproved |
Submissions
| Submission | Status | Status date | Review | Class | Documents |
|---|---|---|---|---|---|
| Original 1 | Approved | priority | Type 1 - New Molecular Entity | Letter for Original 1 (opens in a new tab)Label for Original 1 (opens in a new tab) |
Orange Book patents
No Orange Book patents are listed for this application.
Orange Book exclusivities
| Code | Product | Expires |
|---|---|---|
| NCE | 001 |
Codes as the Orange Book prints them; its preface explains each code.
Prescription labels
No human prescription label in openFDA cites this application.
NDC products
1 product in the NDC directory with this application number.
| Product NDC | Name | Labeler | Form and route | Category | Marketing dates |
|---|---|---|---|---|---|
| 84577-751 in openFDA (opens in a new tab) | REVTORPYK gedatolisib | Celcuity Inc. | INJECTION, POWDER, FOR SOLUTION INTRAVENOUS | NDA | From |
FDA recalls load here.
FDA drug shortages load here.
Sources
- Drugs@FDA (opens in a new tab)Licence: public-domain. Drugs@FDA download 2026-10-25.
- Orange Book (opens in a new tab)Licence: public-domain. Orange Book download 2026-10-25.
- openFDA NDC directory (opens in a new tab)Licence: cc0. openFDA NDC download 2026-10-25.
Data provided by the U.S. Food and Drug Administration. Showing it here is not an FDA endorsement. openFDA asks: “Do not rely on openFDA to make decisions regarding medical care.”
Patent and exclusivity dates are as FDA lists them and can change. Nothing on this page is medical or investment advice.