DUAKLIR PRESSAIR

Basic Information

Product Name

DUAKLIR PRESSAIR

FDA Product Code

0310-0900

Regulatory Information

NDC Product Code

0310-0900

Application Number

NDA210595

Marketing Category

C73594

Effective Date

January 25, 2022

Territorial Authority

USA

FDA Title

These highlights do not include all the information needed to use DUAKLIR PRESSAIR safely and effectively. See full prescribing information for DUAKLIR PRESSAIR.DUAKLIR PRESSAIR (aclidinium bromide and formoterol fumarate) inhalation powder, for oral inhalationInitial U.S. Approval: 2019

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

FORMOTEROL FUMARATE

Quantity: 12 ug in 1 1

Code: W34SHF8J2K

Class Code: ACTIB

LACTOSE MONOHYDRATE

Code: EWQ57Q8I5X

Class Code: IACT

ACLIDINIUM BROMIDE

Quantity: 400 ug in 1 1

Code: UQW7UF9N91

Class Code: ACTIB

Active Moieties

ACLIDINIUM

Code: K17VY42F6C

FORMOTEROL

Code: 5ZZ84GCW8B