Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 211651
Company: PFIZER
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 |
TALZENNA | TALAZOPARIB TOSYLATE | EQ 0.5MG BASE | CAPSULE;ORAL | Prescription | None | Yes | No |
TALZENNA | TALAZOPARIB TOSYLATE | EQ 0.75MG BASE | CAPSULE;ORAL | Prescription | None | Yes | No |
TALZENNA | TALAZOPARIB TOSYLATE | EQ 0.1MG BASE | CAPSULE;ORAL | Prescription | None | Yes | No |
TALZENNA | TALAZOPARIB TOSYLATE | EQ 0.35MG BASE | CAPSULE;ORAL | Prescription | None | Yes | No |
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 |
---|---|---|---|---|---|
02/06/2024 | SUPPL-12 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/211651s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/211651Orig1s012ltr.pdf | |
06/20/2023 | SUPPL-10 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/211651s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/211651Orig1s010ltr.pdf | |
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 |
---|---|---|---|---|---|
02/06/2024 | SUPPL-12 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/211651s012lbl.pdf | |
06/20/2023 | SUPPL-10 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/211651s010lbl.pdf | |
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 |