Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 211651

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TALZENNA (TALAZOPARIB TOSYLATE)
EQ 0.1MG BASE
Marketing Status: Prescription

Active Ingredient: TALAZOPARIB TOSYLATE
Proprietary Name: TALZENNA
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 0.1MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N211651
Product Number: 005
Approval Date: Jun 20, 2023
Applicant Holder Full Name: PFIZER INC
Marketing Status:  Prescription
Patent and Exclusivity Information

TALZENNA (TALAZOPARIB TOSYLATE)
EQ 0.25MG BASE
Marketing Status: Prescription

Active Ingredient: TALAZOPARIB TOSYLATE
Proprietary Name: TALZENNA
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 0.25MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N211651
Product Number: 001
Approval Date: Oct 16, 2018
Applicant Holder Full Name: PFIZER INC
Marketing Status:  Prescription
Patent and Exclusivity Information

TALZENNA (TALAZOPARIB TOSYLATE)
EQ 0.35MG BASE
Marketing Status: Prescription

Active Ingredient: TALAZOPARIB TOSYLATE
Proprietary Name: TALZENNA
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 0.35MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N211651
Product Number: 006
Approval Date: Jun 20, 2023
Applicant Holder Full Name: PFIZER INC
Marketing Status:  Prescription
Patent and Exclusivity Information

TALZENNA (TALAZOPARIB TOSYLATE)
EQ 0.5MG BASE
Marketing Status: Prescription

Active Ingredient: TALAZOPARIB TOSYLATE
Proprietary Name: TALZENNA
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 0.5MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N211651
Product Number: 003
Approval Date: Sep 20, 2021
Applicant Holder Full Name: PFIZER INC
Marketing Status:  Prescription
Patent and Exclusivity Information

TALZENNA (TALAZOPARIB TOSYLATE)
EQ 0.75MG BASE
Marketing Status: Prescription

Active Ingredient: TALAZOPARIB TOSYLATE
Proprietary Name: TALZENNA
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 0.75MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N211651
Product Number: 004
Approval Date: Sep 20, 2021
Applicant Holder Full Name: PFIZER INC
Marketing Status:  Prescription
Patent and Exclusivity Information

TALZENNA (TALAZOPARIB TOSYLATE)
EQ 1MG BASE
Marketing Status: Prescription

Active Ingredient: TALAZOPARIB TOSYLATE
Proprietary Name: TALZENNA
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 1MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N211651
Product Number: 002
Approval Date: Oct 16, 2018
Applicant Holder Full Name: PFIZER INC
Marketing Status:  Prescription
Patent and Exclusivity Information