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FDA NDA · NDA210595

DUAKLIR PRESSAIR

aclidinium bromide and formoterol fumarate

Sponsor: AZURITY

APPLICATION
NDA210595
TYPE
NDA
ORIGINAL APPROVAL
2019-03-29
LATEST ACTION
2019-03-29
ROUTE
RESPIRATORY (INHALATION), INHALATION
DOSAGE FORM
POWDER, METERED
MARKETING STATUS
Prescription

Products

DUAKLIR PRESSAIR · ReferencePrescription
ACLIDINIUM BROMIDE 0.4MG/INH, FORMOTEROL FUMARATE 0.012MG/INH · POWDER, METERED · INHALATION

Approval history

2019-03-29Type 4 - New Combination · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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