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FDA NDA · NDA021936

SPIRIVA RESPIMAT

tiotropium bromide inhalation spray

Sponsor: BOEHRINGER INGELHEIM

APPLICATION
NDA021936
TYPE
NDA
ORIGINAL APPROVAL
2014-09-24
LATEST ACTION
2024-12-27
ROUTE
RESPIRATORY (INHALATION), INHALATION
DOSAGE FORM
SPRAY, METERED
MARKETING STATUS
Prescription

Products

SPIRIVA RESPIMAT · ReferencePrescription
TIOTROPIUM BROMIDE EQ 0.00125MG BASE/INH · SPRAY, METERED · INHALATION
SPIRIVA RESPIMAT · ReferencePrescription
TIOTROPIUM BROMIDE EQ 0.0025MG BASE/INH · SPRAY, METERED · INHALATION

Approval history

2024-12-27Labeling · Supplement 36 · standard — Letter ↗AP
2019-02-14Labeling · Supplement 12 · standard — Label ↗AP
2017-02-15Efficacy · Supplement 7 · priority — Label ↗AP
2016-06-09Labeling · Supplement 5 · standard — Letter ↗AP
2016-01-15Labeling · Supplement 3 · standard — Label ↗AP
2014-09-24Type 3 - New Dosage Form · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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