TABRECTA
NDA 213591 · New Drug Application (NDA) Prescription
CAPMATINIB HYDROCHLORIDE
- Sponsor (Drugs@FDA)
- NOVARTIS PHARM Company: NOVARTIS AG (NVS, NVSEF)
- 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 | TABRECTA CAPMATINIB HYDROCHLORIDE | TABLET;ORAL EQ 150MG BASE | Prescription | – | Reference listed drug | RXApproved |
| 002 | TABRECTA CAPMATINIB HYDROCHLORIDE | TABLET;ORAL EQ 200MG BASE | Prescription | – | Reference listed drug, Reference standard | RXApproved |
Submissions
| Submission | Status | Status date | Review | Class | Documents |
|---|---|---|---|---|---|
| Supplement 11 | Approved | standard | Labeling | Letter for Supplement 11 (opens in a new tab)Label for Supplement 11 (opens in a new tab) | |
| Supplement 7 | Approved | standard | Labeling | Letter for Supplement 7 (opens in a new tab)Label for Supplement 7 (opens in a new tab) | |
| Supplement 4 | Approved | priority | Efficacy | Letter for Supplement 4 (opens in a new tab)Label for Supplement 4 (opens in a new tab) | |
| Supplement 2 | Approved | standard | Labeling | Letter for Supplement 2 (opens in a new tab)Label for Supplement 2 (opens in a new tab) | |
| 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
14 patents listed, as the Orange Book prints them.
| Patent | Expires | Claims | Use code | Submitted |
|---|---|---|---|---|
| 12084449Product 001 | Method of use | U-2813 | ||
| 8461330Product 001 | Drug substance, Drug product | – | ||
| 8901123Product 001 | Method of use | U-2813 | ||
| 8420645Product 001 | Drug substance, Drug product | – | ||
| 7767675Product 001 | Drug substance, Drug product | – | ||
| 10596178Product 001 | Drug product | – | ||
| 12208101Product 001 | Drug product | – | ||
| 12084449Product 002 | Method of use | U-2813 | ||
| 8461330Product 002 | Drug substance, Drug product | – | ||
| 8901123Product 002 | Method of use | U-2813 | ||
| 8420645Product 002 | Drug substance, Drug product | – | ||
| 7767675Product 002 | Drug substance, Drug product | – | ||
| 12208101Product 002 | Drug product | – | ||
| 10596178Product 002 | Drug product | – |
Orange Book exclusivities
| Code | Product | Expires |
|---|---|---|
| ODE-291 | 001 | |
| ODE-291 | 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.
TABRECTA
CAPMATINIB · Novartis Pharmaceuticals Corporation · ORAL · Version 17 · effective
Indications and usage
1 INDICATIONS AND USAGE TABRECTA is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to mesenchymal-epithelial transition (MET) exon 14 skipping as detected by an FDA-approved test. TABRECTA is a kinase inhibitor indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to mesenchymal-epithelial transition (MET) exon 14 skipping as detected by an FDA-approved test.
NDC products
2 products in the NDC directory with this application number.
| Product NDC | Name | Labeler | Form and route | Category | Marketing dates |
|---|---|---|---|---|---|
| 0078-0709 in openFDA (opens in a new tab) | TABRECTA capmatinib | Novartis Pharmaceuticals Corporation | TABLET, FILM COATED ORAL | NDA | From |
| 0078-0716 in openFDA (opens in a new tab) | TABRECTA capmatinib | Novartis Pharmaceuticals Corporation | 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.