DUAKLIR PRESSAIR
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
Approved
Approval ID
2eba3089-28b4-4190-9fba-2511246cfd16
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 1, 2022
Manufacturers
FDA
Covis Pharma US, Inc
DUNS: 118094829
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
aclidinium bromide and formoterol fumarate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70515-001
Application NumberNDA210595
Product Classification
M
Marketing Category
C73594
G
Generic Name
aclidinium bromide and formoterol fumarate
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateAugust 1, 2022
FDA Product Classification
INGREDIENTS (3)
ACLIDINIUM BROMIDEActive
Quantity: 400 ug in 1 1
Code: UQW7UF9N91
Classification: ACTIB
FORMOTEROL FUMARATEActive
Quantity: 12 ug in 1 1
Code: W34SHF8J2K
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT