Product Details for NDA 217439
TALZENNA (TALAZOPARIB TOSYLATE)
EQ 0.1MG BASE
Marketing Status: Prescription
EQ 0.25MG BASE
Marketing Status: Prescription
EQ 0.35MG BASE
Marketing Status: Prescription
EQ 0.5MG BASE
Marketing Status: Prescription
EQ 0.75MG BASE
Marketing Status: Prescription
EQ 1MG BASE
Marketing Status: Prescription
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: N217439
Product Number: 001
Approval Date: Mar 7, 2024
Applicant Holder Full Name: PFIZER INC
Marketing Status: Prescription
Patent and Exclusivity Information
TALZENNA (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: N217439
Product Number: 001
Approval Date: Mar 7, 2024
Applicant Holder Full Name: PFIZER INC
Marketing Status: Prescription
Patent and Exclusivity Information
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: N217439
Product Number: 002
Approval Date: Mar 7, 2024
Applicant Holder Full Name: PFIZER INC
Marketing Status: Prescription
Patent and Exclusivity Information
TALZENNA (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: N217439
Product Number: 002
Approval Date: Mar 7, 2024
Applicant Holder Full Name: PFIZER INC
Marketing Status: Prescription
Patent and Exclusivity Information
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: N217439
Product Number: 003
Approval Date: Mar 7, 2024
Applicant Holder Full Name: PFIZER INC
Marketing Status: Prescription
Patent and Exclusivity Information
TALZENNA (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: N217439
Product Number: 003
Approval Date: Mar 7, 2024
Applicant Holder Full Name: PFIZER INC
Marketing Status: Prescription
Patent and Exclusivity Information
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: N217439
Product Number: 004
Approval Date: Mar 7, 2024
Applicant Holder Full Name: PFIZER INC
Marketing Status: Prescription
Patent and Exclusivity Information
TALZENNA (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: N217439
Product Number: 004
Approval Date: Mar 7, 2024
Applicant Holder Full Name: PFIZER INC
Marketing Status: Prescription
Patent and Exclusivity Information
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: N217439
Product Number: 005
Approval Date: Mar 7, 2024
Applicant Holder Full Name: PFIZER INC
Marketing Status: Prescription
Patent and Exclusivity Information
TALZENNA (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: N217439
Product Number: 005
Approval Date: Mar 7, 2024
Applicant Holder Full Name: PFIZER INC
Marketing Status: Prescription
Patent and Exclusivity Information
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: N217439
Product Number: 006
Approval Date: Mar 7, 2024
Applicant Holder Full Name: PFIZER INC
Marketing Status: Prescription
Patent and Exclusivity Information
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: N217439
Product Number: 006
Approval Date: Mar 7, 2024
Applicant Holder Full Name: PFIZER INC
Marketing Status: Prescription
Patent and Exclusivity Information