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
25a4cb05-64a8-44b6-88c8-4292a5292e92
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 15, 2020
Manufacturers
FDA
A-S Medication Solutions
DUNS: 830016429
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 Code50090-4414
Application NumberNDA021395
Marketing CategoryC73594
Route of AdministrationORAL, RESPIRATORY (INHALATION)
Effective DateOctober 1, 2019
Generic NameTIOTROPIUM BROMIDE
INGREDIENTS (1)
TIOTROPIUM BROMIDE MONOHYDRATEActive
Quantity: 18 ug in 1 1
Code: L64SXO195N
Classification: ACTIM