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FDA Approval

Spiriva

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Effective Date
February 6, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Tiotropium(18 ug in 1 1)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

A-S Medication Solutions

A-S Medication Solutions

830016429

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Spiriva HandiHaler

Product Details

NDC Product Code
50090-4248
Application Number
NDA021395
Marketing Category
NDA (C73594)
Route of Administration
ORAL, RESPIRATORY (INHALATION)
Effective Date
November 30, 2021
Code: L64SXO195NClass: ACTIMQuantity: 18 ug in 1 1
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