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Approved Drug Products containing Talazoparib Tosylate listed in the FDA Orange Book. Original Data : FDA Website

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01

Discovery on Target
Not Confirmed
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Discovery on Target
Not Confirmed

TALAZOPARIB TOSYLATE

Brand Name : TALZENNA

Dosage Form : CAPSULE;ORAL

Dosage Strength : EQ 0.25MG BASE

Approval Date : 2018-10-16

Application Number : 211651

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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02

Discovery on Target
Not Confirmed
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Discovery on Target
Not Confirmed

TALAZOPARIB TOSYLATE

Brand Name : TALZENNA

Dosage Form : CAPSULE;ORAL

Dosage Strength : EQ 1MG BASE

Approval Date : 2018-10-16

Application Number : 211651

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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03

Discovery on Target
Not Confirmed
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Discovery on Target
Not Confirmed

TALAZOPARIB TOSYLATE

Brand Name : TALZENNA

Dosage Form : CAPSULE;ORAL

Dosage Strength : EQ 0.5MG BASE

Approval Date : 2021-09-20

Application Number : 211651

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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04

Discovery on Target
Not Confirmed
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Discovery on Target
Not Confirmed

TALAZOPARIB TOSYLATE

Brand Name : TALZENNA

Dosage Form : CAPSULE;ORAL

Dosage Strength : EQ 0.75MG BASE

Approval Date : 2021-09-20

Application Number : 211651

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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05

Discovery on Target
Not Confirmed
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Discovery on Target
Not Confirmed

TALAZOPARIB TOSYLATE

Brand Name : TALZENNA

Dosage Form : CAPSULE;ORAL

Dosage Strength : EQ 0.1MG BASE

Approval Date : 2023-06-20

Application Number : 211651

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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06

Discovery on Target
Not Confirmed
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Discovery on Target
Not Confirmed

TALAZOPARIB TOSYLATE

Brand Name : TALZENNA

Dosage Form : CAPSULE;ORAL

Dosage Strength : EQ 0.35MG BASE

Approval Date : 2023-06-20

Application Number : 211651

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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07

Discovery on Target
Not Confirmed
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Discovery on Target
Not Confirmed

TALAZOPARIB TOSYLATE

Brand Name : TALZENNA

Dosage Form : CAPSULE;ORAL

Dosage Strength : EQ 0.1MG BASE

Approval Date : 2024-03-07

Application Number : 217439

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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08

Discovery on Target
Not Confirmed
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Discovery on Target
Not Confirmed

TALAZOPARIB TOSYLATE

Brand Name : TALZENNA

Dosage Form : CAPSULE;ORAL

Dosage Strength : EQ 0.25MG BASE

Approval Date : 2024-03-07

Application Number : 217439

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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09

Discovery on Target
Not Confirmed
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Discovery on Target
Not Confirmed

TALAZOPARIB TOSYLATE

Brand Name : TALZENNA

Dosage Form : CAPSULE;ORAL

Dosage Strength : EQ 0.35MG BASE

Approval Date : 2024-03-07

Application Number : 217439

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

blank

10

Discovery on Target
Not Confirmed
arrow
arrow
Discovery on Target
Not Confirmed

TALAZOPARIB TOSYLATE

Brand Name : TALZENNA

Dosage Form : CAPSULE;ORAL

Dosage Strength : EQ 0.5MG BASE

Approval Date : 2024-03-07

Application Number : 217439

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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