U.S. flag An official website of the United States government

U.S. Food and Drug Administration
  1. Home
  2. Drug Databases
  3. Drugs@FDA

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 217439
Company: PFIZER

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

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)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217439s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/217439Orig1s000ltr.pdf

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
03/07/2024 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217439s000lbl.pdf
Back to Top