Tudorza Pressair
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
Approved
Approval ID
6f92cceb-a63f-4470-99b6-56179d98f10f
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
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70515-002
Application NumberNDA202450
Product Classification
M
Marketing Category
C73594
G
Generic Name
aclidinium bromide
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateAugust 1, 2022
FDA Product Classification
INGREDIENTS (2)
lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
ACLIDINIUM BROMIDEActive
Quantity: 400 ug in 1 1
Code: UQW7UF9N91
Classification: ACTIB