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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 208447

ZEJULA (NIRAPARIB TOSYLATE)
EQ 100MG BASE
Marketing Status: Discontinued
Active Ingredient: NIRAPARIB TOSYLATE
Proprietary Name: ZEJULA
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 100MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N208447
Product Number: 001
Approval Date: Mar 27, 2017
Applicant Holder Full Name: GLAXOSMITHKLINE LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information
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