Spiriva Respimat
These highlights do not include all the information needed to use SPIRIVA RESPIMAT safely and effectively. See full prescribing information for SPIRIVA RESPIMAT. SPIRIVA® RESPIMAT® (tiotropium bromide inhalation spray), for oral inhalation use Initial U.S. Approval: 2004
Approved
Approval ID
7b656b14-fcaa-2741-f6f0-e0be48971c02
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 2, 2023
Manufacturers
FDA
Boehringer Ingelheim Pharmaceuticals, Inc.
DUNS: 603175944
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
tiotropium bromide inhalation spray
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0597-0100
Application NumberNDA021936
Product Classification
M
Marketing Category
C73594
G
Generic Name
tiotropium bromide inhalation spray
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateOctober 2, 2023
FDA Product Classification
INGREDIENTS (1)
TIOTROPIUM BROMIDE ANHYDROUSActive
Quantity: 3.124 ug in 1 1
Code: XX112XZP0J
Classification: ACTIB
tiotropium bromide inhalation spray
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0597-0160
Application NumberNDA207070
Product Classification
M
Marketing Category
C73594
G
Generic Name
tiotropium bromide inhalation spray
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateOctober 2, 2023
FDA Product Classification
INGREDIENTS (1)
TIOTROPIUM BROMIDE ANHYDROUSActive
Quantity: 1.562 ug in 1 1
Code: XX112XZP0J
Classification: ACTIB