← FDA DRUG APPROVALS

FDA NDA · NDA217439

TALZENNA

talazoparib

Sponsor: PFIZER

APPLICATION
NDA217439
TYPE
NDA
ORIGINAL APPROVAL
2024-03-07
LATEST ACTION
2025-06-12
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

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

Approval history

2025-06-12Efficacy · Supplement 3 · priority — Label ↗AP
2024-03-07Type 5 - New Formulation or New Manufacturer · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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