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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 211710
Company: BAYER HEALTHCARE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VITRAKVI LAROTRECTINIB SULFATE EQ 20MG BASE/ML SOLUTION;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
11/26/2018 ORIG-1 Approval Type 3 - New Dosage Form PRIORITY; Orphan Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211710s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/211710Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210861Orig1s000_21171Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/25/2021 SUPPL-5 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/211710s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/211710Orig1s005ltr.pdf
03/25/2021 SUPPL-4 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/211710s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/211710Orig1s004ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/25/2021 SUPPL-5 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/211710s005lbl.pdf
03/25/2021 SUPPL-4 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/211710s004lbl.pdf
11/26/2018 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211710s000lbl.pdf
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