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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 208261

ZEPATIER (ELBASVIR; GRAZOPREVIR)
50MG;100MG
Marketing Status: Prescription
Active Ingredient: ELBASVIR; GRAZOPREVIR
Proprietary Name: ZEPATIER
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 50MG;100MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N208261
Product Number: 001
Approval Date: Jan 28, 2016
Applicant Holder Full Name: MERCK SHARP AND DOHME LLC A SUB OF MERCK AND CO INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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