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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 213591
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
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
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
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