Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Home | Back to Search Results

Product Details for NDA 214876

Expand all

ZEJULA (NIRAPARIB TOSYLATE)
EQ 100MG BASE
Marketing Status: Prescription

Active Ingredient: NIRAPARIB TOSYLATE
Proprietary Name: ZEJULA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 100MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N214876
Product Number: 001
Approval Date: Apr 26, 2023
Applicant Holder Full Name: GLAXOSMITHKLINE LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

ZEJULA (NIRAPARIB TOSYLATE)
EQ 200MG BASE
Marketing Status: Prescription

Active Ingredient: NIRAPARIB TOSYLATE
Proprietary Name: ZEJULA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 200MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N214876
Product Number: 002
Approval Date: Apr 26, 2023
Applicant Holder Full Name: GLAXOSMITHKLINE LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

ZEJULA (NIRAPARIB TOSYLATE)
EQ 300MG BASE
Marketing Status: Prescription

Active Ingredient: NIRAPARIB TOSYLATE
Proprietary Name: ZEJULA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 300MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N214876
Product Number: 003
Approval Date: Apr 26, 2023
Applicant Holder Full Name: GLAXOSMITHKLINE LLC
Marketing Status:  Prescription
Patent and Exclusivity Information