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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 211651
Company: PFIZER

Products on NDA 211651

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 211651

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

Labels for NDA 211651

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

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