Striverdi Respimat
These highlights do not include all the information needed to use STRIVERDI RESPIMAT safely and effectively. See full prescribing information for STRIVERDI RESPIMAT. STRIVERDI RESPIMAT (olodaterol inhalation spray), for oral inhalation use Initial U.S. Approval: 2014
Approved
Approval ID
5d9a5433-857e-44ea-b3d6-2a400ca0cef5
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 23, 2023
Manufacturers
FDA
Boehringer Ingelheim Pharmaceuticals, Inc.
DUNS: 603175944
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
olodaterol respimat inhalation spray
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0597-0192
Application NumberNDA203108
Product Classification
M
Marketing Category
C73594
G
Generic Name
olodaterol respimat inhalation spray
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateMay 23, 2023
FDA Product Classification
INGREDIENTS (1)
OLODATEROL HYDROCHLORIDEActive
Quantity: 2.5 ug in 1 1
Code: 65R445W3V9
Classification: ACTIM