Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 210595

DUAKLIR PRESSAIR (ACLIDINIUM BROMIDE; FORMOTEROL FUMARATE)
0.4MG/INH;0.012MG/INH Marketing Status: Prescription

Active Ingredient: ACLIDINIUM BROMIDE; FORMOTEROL FUMARATE
Proprietary Name: DUAKLIR PRESSAIR
Dosage Form; Route of Administration: POWDER, METERED; INHALATION
Strength: 0.4MG/INH;0.012MG/INH
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N210595
Product Number: 001
Approval Date: Mar 29, 2019
Applicant Holder Full Name: CIRCASSIA LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

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