Spiriva
These highlights do not include all the information needed to use SPIRIVA HANDIHALER safely and effectively. See full prescribing information for SPIRIVA HANDIHALER. SPIRIVA® HANDIHALER® (tiotropium bromide inhalation powder), for oral inhalation use Initial U.S. Approval: 2004
Approved
Approval ID
820839ef-e53d-47e8-a3b9-d911ff92e6a9
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 19, 2022
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.
TIOTROPIUM BROMIDE
PRODUCT DETAILS
NDC Product Code0597-0075
Application NumberNDA021395
Marketing CategoryC73594
Route of AdministrationORAL, RESPIRATORY (INHALATION)
Effective DateNovember 30, 2021
Generic NameTIOTROPIUM BROMIDE
INGREDIENTS (1)
TIOTROPIUM BROMIDE MONOHYDRATEActive
Quantity: 18 ug in 1 1
Code: L64SXO195N
Classification: ACTIM