Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 211651
Company: PFIZER
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TALZENNA TALAZOPARIB TOSYLATE EQ 0.25MG BASE CAPSULE;ORAL Prescription None Yes No
TALZENNA TALAZOPARIB TOSYLATE EQ 1MG BASE 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
10/16/2018 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211651s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/211651Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/211651Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/21/2021 SUPPL-9 Manufacturing (CMC)-New Strength Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/211651Orig1s008, s009ltr.pdf
09/20/2021 SUPPL-8 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/211651s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/211651Orig1s008, s009ltr.pdf
09/09/2021 SUPPL-7 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/211651s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/211651Orig1s007ltr.pdf
10/22/2020 SUPPL-6 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/211651s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/211651Orig1s006ltr.pdf
03/09/2020 SUPPL-5 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/211651s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/211651Orig1s005ltr.pdf
09/24/2019 SUPPL-2 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211651s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/211651Orig1s002ltr.pdf
06/16/2021 SUPPL-1 Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/211651Orig1s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
09/20/2021 SUPPL-8 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/211651s008lbl.pdf
09/09/2021 SUPPL-7 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/211651s007lbl.pdf
10/22/2020 SUPPL-6 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/211651s006lbl.pdf
03/09/2020 SUPPL-5 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/211651s005lbl.pdf
09/24/2019 SUPPL-2 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211651s002lbl.pdf
10/16/2018 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211651s000lbl.pdf

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