Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 207930

UTIBRON (GLYCOPYRROLATE ; INDACATEROL MALEATE)
15.6MCG/INH;27.5MCG/INH Marketing Status: Prescription

Active Ingredient: GLYCOPYRROLATE ; INDACATEROL MALEATE
Proprietary Name: UTIBRON
Dosage Form; Route of Administration: POWDER; INHALATION
Strength: 15.6MCG/INH;27.5MCG/INH
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N207930
Product Number: 001
Approval Date: Oct 29, 2015
Applicant Holder Full Name: SUNOVION PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

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