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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50090-4414
Application NumberNDA021395
Product Classification
M
Marketing Category
C73594
G
Generic Name
TIOTROPIUM BROMIDE
Product Specifications
Route of AdministrationORAL, RESPIRATORY (INHALATION)
Effective DateOctober 1, 2019
FDA Product Classification
INGREDIENTS (1)
TIOTROPIUM BROMIDE MONOHYDRATEActive
Quantity: 18 ug in 1 1
Code: L64SXO195N
Classification: ACTIM