Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 211710
Company: BAYER HEALTHCARE
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 |
---|---|---|---|---|---|
11/03/2023 | SUPPL-9 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/211710s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/211710Orig1s009ltr.pdf | |
11/23/2022 | SUPPL-8 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/211710s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/211710Orig1s008ltr.pdf | |
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 |
---|---|---|---|---|---|
11/03/2023 | SUPPL-9 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/211710s009lbl.pdf | |
11/23/2022 | SUPPL-8 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/211710s008lbl.pdf | |
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 |