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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 205382

INCRUSE ELLIPTA (UMECLIDINIUM BROMIDE)
EQ 62.5MCG BASE/INH
Marketing Status: Prescription
Active Ingredient: UMECLIDINIUM BROMIDE
Proprietary Name: INCRUSE ELLIPTA
Dosage Form; Route of Administration: POWDER; INHALATION
Strength: EQ 62.5MCG BASE/INH
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N205382
Product Number: 001
Approval Date: Apr 30, 2014
Applicant Holder Full Name: GLAXO GROUP LTD ENGLAND DBA GLAXOSMITHKLINE
Marketing Status:  Prescription
Patent and Exclusivity Information
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