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FDA Product

Tudorza Pressair

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Tudorza Pressair

0310-0800

Regulatory Information

0310-0800

NDA202450

C73594

February 23, 2021

USA

These highlights do not include all the information needed to use TUDORZA PRESSAIR safely and effectively. See full prescribing information for TUDORZA PRESSAIR. TUDORZA PRESSAIR (aclidinium bromide inhalation powder)FOR ORAL INHALATION ONLYInitial U.S. Approval: 2012

HUMAN PRESCRIPTION DRUG LABEL

20

Company Information

054743190

Active Ingredients

ACLIDINIUM BROMIDE

Quantity: 400 ug in 1 1

Code: UQW7UF9N91

Class Code: ACTIB

lactose monohydrate

Code: EWQ57Q8I5X

Class Code: IACT

Active Moieties

ACLIDINIUM

Code: K17VY42F6C

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