Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021395

SPIRIVA (TIOTROPIUM BROMIDE)
EQ 0.018MG BASE/INH
Marketing Status: Prescription
Active Ingredient: TIOTROPIUM BROMIDE
Proprietary Name: SPIRIVA
Dosage Form; Route of Administration: POWDER; INHALATION
Strength: EQ 0.018MG BASE/INH
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N021395
Product Number: 001
Approval Date: Jan 30, 2004
Applicant Holder Full Name: BOEHRINGER INGELHEIM PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

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