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FDA NDA · NDA207070

SPIRIVA RESPIMAT

tiotropium bromide inhalation spray

Sponsor: BOEHRINGER INGELHEIM

APPLICATION
NDA207070
TYPE
NDA
ORIGINAL APPROVAL
2015-09-15
LATEST ACTION
2015-09-15
ROUTE
RESPIRATORY (INHALATION), INHALATION
DOSAGE FORM
SPRAY
MARKETING STATUS
Prescription

Products

SPIRIVA RESPIMATPrescription
TIOTROPIUM BROMIDE 2.5MCG · SPRAY · INHALATION

Approval history

2015-09-15Type 9 - New Indication Submitted as Distinct NDA, Consolidated with Original NDA after Approval · Original · standard — Label ↗AP
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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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