NDC 0069-0296

Talzenna

Talazoparib

Talzenna is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Pfizer Laboratories Div Pfizer Inc. The primary component is Talazoparib Tosylate.

Product ID0069-0296_054b5fec-a4ea-4bb5-8222-a6c931557ee3
NDC0069-0296
Product TypeHuman Prescription Drug
Proprietary NameTalzenna
Generic NameTalazoparib
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2018-10-26
Marketing CategoryNDA / NDA
Application NumberNDA211651
Labeler NamePfizer Laboratories Div Pfizer Inc
Substance NameTALAZOPARIB TOSYLATE
Active Ingredient Strength0 mg/1
Pharm ClassesPoly(ADP-Ribose) Polymerase Inhibitor [EPC],Poly(ADP-Ribose) Polymerase Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 0069-0296-30

30 CAPSULE in 1 BOTTLE (0069-0296-30)
Marketing Start Date2018-10-26
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0069-0296-30 [00069029630]

Talzenna CAPSULE
Marketing CategoryNDA
Application NumberNDA211651
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-10-26

Drug Details

Active Ingredients

IngredientStrength
TALAZOPARIB TOSYLATE.25 mg/1

OpenFDA Data

SPL SET ID:f2423edd-6d24-495c-aec1-c2f457f08d9a
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 2099954
  • 2099956
  • 2099946
  • 2099952
  • Pharmacological Class

    • Poly(ADP-Ribose) Polymerase Inhibitor [EPC]
    • Poly(ADP-Ribose) Polymerase Inhibitors [MoA]

    NDC Crossover Matching brand name "Talzenna" or generic name "Talazoparib"

    NDCBrand NameGeneric Name
    0069-0296Talzennatalazoparib
    0069-1195Talzennatalazoparib
    0069-1501Talzennatalazoparib
    0069-1751Talzennatalazoparib
    46014-0296Talzennatalazoparib
    46014-1195Talzennatalazoparib
    63539-295Talzennatalazoparib

    Trademark Results [Talzenna]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    TALZENNA
    TALZENNA
    87293680 not registered Dead/Abandoned
    Wyeth LLC
    2017-01-09
    TALZENNA
    TALZENNA
    86253764 5291322 Live/Registered
    Wyeth LLC
    2014-04-16
    TALZENNA
    TALZENNA
    85173532 not registered Dead/Abandoned
    Wyeth LLC
    2010-11-10
    TALZENNA
    TALZENNA
    77180181 not registered Dead/Abandoned
    WYETH LLC
    2007-05-14

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.