Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021936

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SPIRIVA RESPIMAT (TIOTROPIUM BROMIDE)
EQ 0.00125MG BASE/INH
Marketing Status: Prescription
Active Ingredient: TIOTROPIUM BROMIDE
Proprietary Name: SPIRIVA RESPIMAT
Dosage Form; Route of Administration: SPRAY, METERED; INHALATION
Strength: EQ 0.00125MG BASE/INH
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021936
Product Number: 002
Approval Date: Sep 15, 2015
Applicant Holder Full Name: BOEHRINGER INGELHEIM PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
SPIRIVA RESPIMAT (TIOTROPIUM BROMIDE)
EQ 0.0025MG BASE/INH
Marketing Status: Prescription
Active Ingredient: TIOTROPIUM BROMIDE
Proprietary Name: SPIRIVA RESPIMAT
Dosage Form; Route of Administration: SPRAY, METERED; INHALATION
Strength: EQ 0.0025MG BASE/INH
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N021936
Product Number: 001
Approval Date: Sep 24, 2014
Applicant Holder Full Name: BOEHRINGER INGELHEIM PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

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