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New Drug Application (NDA): 213721
Company: GENENTECH INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
GAVRETO PRALSETINIB 100MG CAPSULE;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
09/04/2020 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY; Orphan Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/213721Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/20/2023 SUPPL-14 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/213721s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/213721Orig1s014ltr.pdf
06/30/2023 SUPPL-11 Labeling-Package Insert, Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/213721s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/213721Orig1s011ltr.pdf
08/09/2023 SUPPL-9 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/213721s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/213721Orig1s009ltr.pdf
09/28/2022 SUPPL-7 Labeling-Container/Carton Labels, Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/213721s007lbl.pdf
02/02/2022 SUPPL-5 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/213721s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/213721Orig1s005ltr.pdf
11/10/2021 SUPPL-4 Labeling-Patient Package Insert, Labeling-Container/Carton Labels, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/213721s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/213721Orig1s004ltr.pdf
09/04/2020 SUPPL-1 Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213721s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/213721Orig1s000ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/09/2023 SUPPL-9 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/213721s009lbl.pdf
07/20/2023 SUPPL-14 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/213721s014lbl.pdf
06/30/2023 SUPPL-11 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/213721s011lbl.pdf
06/30/2023 SUPPL-11 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/213721s011lbl.pdf
09/28/2022 SUPPL-7 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/213721s007lbl.pdf
09/28/2022 SUPPL-7 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/213721s007lbl.pdf
02/02/2022 SUPPL-5 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/213721s005lbl.pdf
11/10/2021 SUPPL-4 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/213721s004lbl.pdf
11/10/2021 SUPPL-4 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/213721s004lbl.pdf
11/10/2021 SUPPL-4 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/213721s004lbl.pdf
09/04/2020 SUPPL-1 Type 1 - New Molecular Entity Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213721s000lbl.pdf
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