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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 203975

ANORO ELLIPTA (UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE)
EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH
Marketing Status: Prescription
Active Ingredient: UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE
Proprietary Name: ANORO ELLIPTA
Dosage Form; Route of Administration: POWDER; INHALATION
Strength: EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N203975
Product Number: 001
Approval Date: Dec 18, 2013
Applicant Holder Full Name: GLAXOSMITHKLINE INTELLECTUAL PROPERTY DEVELOPMENT LTD ENGLAND
Marketing Status:  Prescription
Patent and Exclusivity Information
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