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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 206756

STIOLTO RESPIMAT (OLODATEROL HYDROCHLORIDE; TIOTROPIUM BROMIDE)
EQ 0.0025MG BASE/INH;EQ 0.0025MG BASE/INH
Marketing Status: Prescription
Active Ingredient: OLODATEROL HYDROCHLORIDE; TIOTROPIUM BROMIDE
Proprietary Name: STIOLTO RESPIMAT
Dosage Form; Route of Administration: SPRAY, METERED; INHALATION
Strength: EQ 0.0025MG BASE/INH;EQ 0.0025MG BASE/INH
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N206756
Product Number: 001
Approval Date: May 21, 2015
Applicant Holder Full Name: BOEHRINGER INGELHEIM PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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