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FDA NDA · NDA211651

TALZENNA

talazoparib

Sponsor: PFIZER

APPLICATION
NDA211651
TYPE
NDA
ORIGINAL APPROVAL
2018-10-16
LATEST ACTION
2025-06-12
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

TALZENNA · ReferenceDiscontinued
TALAZOPARIB TOSYLATE EQ 0.1MG BASE · CAPSULE · ORAL
TALZENNA · ReferenceDiscontinued
TALAZOPARIB TOSYLATE EQ 0.5MG BASE · CAPSULE · ORAL
TALZENNA · ReferenceDiscontinued
TALAZOPARIB TOSYLATE EQ 0.25MG BASE · CAPSULE · ORAL
TALZENNA · ReferenceDiscontinued
TALAZOPARIB TOSYLATE EQ 0.35MG BASE · CAPSULE · ORAL
TALZENNA · ReferenceDiscontinued
TALAZOPARIB TOSYLATE EQ 0.75MG BASE · CAPSULE · ORAL
TALZENNA · ReferenceDiscontinued
TALAZOPARIB TOSYLATE EQ 1MG BASE · CAPSULE · ORAL

Approval history

2025-06-12Efficacy · Supplement 13 · priority — Label ↗AP
2024-02-06Labeling · Supplement 12 · standard — Letter ↗AP
2023-06-20Efficacy · Supplement 10 · priority — Label ↗AP
2021-09-21Manufacturing (CMC) · Supplement 9 — Letter ↗AP
2021-09-20Labeling · Supplement 8 · standard — Label ↗AP
2021-09-09Efficacy · Supplement 7 · standard — Label ↗AP
2021-06-16Labeling · Supplement 1 · standard — Letter ↗AP
2020-10-22Efficacy · Supplement 6 · standard — Letter ↗AP
2020-03-09Efficacy · Supplement 5 · standard — Letter ↗AP
2019-09-24Efficacy · Supplement 2 · standard — Label ↗AP
2018-10-16Type 1 - New Molecular Entity · Original · priority — Label ↗AP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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