Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 213591
Company: NOVARTIS PHARM
Company: NOVARTIS PHARM
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TABRECTA | CAPMATINIB HYDROCHLORIDE | EQ 150MG BASE | TABLET;ORAL | Prescription | None | Yes | No |
| TABRECTA | CAPMATINIB HYDROCHLORIDE | EQ 200MG BASE | TABLET;ORAL | Prescription | None | Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 05/06/2020 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY; Orphan |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213591s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/213591Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/213591Orig1s000TOC.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/14/2024 | SUPPL-11 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/213591s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/213591Orig1s011ltr.pdf | |
| 03/24/2023 | SUPPL-7 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/213591s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/213591Orig1s007ltr.pdf | |
| 08/10/2022 | SUPPL-4 | Efficacy-Accelerated Approval |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/213591s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/213591Orig1s004ltr.pdf | |
| 01/21/2022 | SUPPL-2 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/213591s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/213591Orig1s002ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 03/14/2024 | SUPPL-11 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/213591s011lbl.pdf | |
| 03/24/2023 | SUPPL-7 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/213591s007lbl.pdf | |
| 03/24/2023 | SUPPL-7 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/213591s007lbl.pdf | |
| 08/10/2022 | SUPPL-4 | Efficacy-Accelerated Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/213591s004lbl.pdf | |
| 01/21/2022 | SUPPL-2 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/213591s002lbl.pdf | |
| 05/06/2020 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213591s000lbl.pdf |