Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 202450

TUDORZA PRESSAIR (ACLIDINIUM BROMIDE)
0.4MG/INH Marketing Status: Prescription

Active Ingredient: ACLIDINIUM BROMIDE
Proprietary Name: TUDORZA PRESSAIR
Dosage Form; Route of Administration: POWDER, METERED; INHALATION
Strength: 0.4MG/INH
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N202450
Product Number: 001
Approval Date: Jul 23, 2012
Applicant Holder Full Name: ASTRAZENECA PHARMACEUTICALS LP
Marketing Status:  Prescription
Patent and Exclusivity Information

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