Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 022383

ARCAPTA NEOHALER (INDACATEROL MALEATE)
EQ 75MCG BASE Marketing Status: Prescription

Active Ingredient: INDACATEROL MALEATE
Proprietary Name: ARCAPTA NEOHALER
Dosage Form; Route of Administration: POWDER; INHALATION
Strength: EQ 75MCG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N022383
Product Number: 001
Approval Date: Jul 1, 2011
Applicant Holder Full Name: SUNOVION PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

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