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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 217439
Company: PFIZER

Products on NDA 217439

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TALZENNA	TALAZOPARIB TOSYLATE	EQ 0.1MG BASE	CAPSULE;ORAL	Prescription	None	Yes	No
TALZENNA	TALAZOPARIB TOSYLATE	EQ 0.25MG BASE	CAPSULE;ORAL	Prescription	None	Yes	No
TALZENNA	TALAZOPARIB TOSYLATE	EQ 0.35MG BASE	CAPSULE;ORAL	Prescription	None	Yes	No
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 1MG BASE	CAPSULE;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 217439

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/07/2024	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217439s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/217439Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/217439Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/12/2025	SUPPL-3	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/217439s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/211651Orig1s013,217439Orig1s003ltr.pdf

Labels for NDA 217439

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/12/2025	SUPPL-3	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/217439s003lbl.pdf
03/07/2024	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217439s000lbl.pdf

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