JIDEYTRO
NDA 220185 · New Drug Application (NDA) Prescription
ZIDESAMTINIB
- Sponsor (Drugs@FDA)
- NUVALENT Company: Nuvalent, Inc.
- 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 | JIDEYTRO ZIDESAMTINIB | TABLET;ORAL 25MG | Prescription | – | Reference listed drug | RXApproved |
| 002 | JIDEYTRO ZIDESAMTINIB | TABLET;ORAL 100MG | Prescription | – | Reference listed drug, Reference standard | RXApproved |
Submissions
| Submission | Status | Status date | Review | Class | Documents |
|---|---|---|---|---|---|
| Original 1 | Approved | standard | 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
8 patents listed, as the Orange Book prints them.
| Patent | Expires | Claims | Use code | Submitted |
|---|---|---|---|---|
| 12054498Product 001 | Method of use | U-4579 | ||
| 11542278Product 001 | Drug substance, Drug product | – | ||
| 12043626Product 001 | Drug substance, Drug product | – | ||
| 12630560Product 001 | Method of use | U-4579 | ||
| 11542278Product 002 | Drug substance, Drug product | – | ||
| 12054498Product 002 | Method of use | U-4579 | ||
| 12630560Product 002 | Method of use | U-4579 | ||
| 12043626Product 002 | Drug substance, Drug product | – |
Orange Book exclusivities
| Code | Product | Expires |
|---|---|---|
| NCE | 001 | |
| NCE | 002 |
Codes as the Orange Book prints them; its preface explains each code.
Prescription labels
The latest version of each DailyMed label, newest first. Indications and boxed warnings are cut to 1,000 characters; DailyMed has the full label.
JIDEYTRO
ZIDESAMTINIB · Nuvalent, Inc. · ORAL · Version 5 · effective
Indications and usage
1 INDICATIONS AND USAGE JIDEYTRO is indicated for the treatment of adult patients with locally advanced or metastatic ROS1 -positive non-small cell lung cancer (NSCLC) who received a prior ROS1 kinase inhibitor [see Dosage and Administration ( 2.1 ), Clinical Studies ( 14.1 )] . JIDEYTRO is a kinase inhibitor indicated for the treatment of adult patients with locally advanced or metastatic ROS1 -positive non-small cell lung cancer (NSCLC) who received a prior ROS1 kinase inhibitor.( 1 )
NDC products
2 products in the NDC directory with this application number.
| Product NDC | Name | Labeler | Form and route | Category | Marketing dates |
|---|---|---|---|---|---|
| 85001-101 in openFDA (opens in a new tab) | JIDEYTRO zidesamtinib | Nuvalent, Inc. | TABLET, FILM COATED ORAL | NDA | From |
| 85001-102 in openFDA (opens in a new tab) | JIDEYTRO zidesamtinib | Nuvalent, Inc. | TABLET, FILM COATED ORAL | 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 drug labels (DailyMed SPL) (opens in a new tab)Licence: cc0. openFDA drug label 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.