← FDA DRUG APPROVALS

FDA NDA · NDA021395

SPIRIVA HANDIHALER

tiotropium bromide

Sponsor: BOEHRINGER INGELHEIM

APPLICATION
NDA021395
TYPE
NDA
ORIGINAL APPROVAL
2004-01-30
LATEST ACTION
2024-12-30
ROUTE
ORAL, RESPIRATORY (INHALATION), INHALATION
DOSAGE FORM
POWDER
MARKETING STATUS
Prescription

Products

SPIRIVA · ReferencePrescription
TIOTROPIUM BROMIDE EQ 0.018MG BASE/INH · POWDER · INHALATION

Approval history

2024-12-30Labeling · Supplement 78 · standard — Label ↗AP
2018-02-01Labeling · Supplement 48 · standard — Label ↗AP
2016-06-23Labeling · Supplement 44 · standard — Letter ↗AP
2016-04-29Manufacturing (CMC) · Supplement 42 · standardAP
2016-03-24Manufacturing (CMC) · Supplement 41 · standardAP
2015-12-10Labeling · Supplement 40 · standard — Letter ↗AP
2015-10-26Manufacturing (CMC) · Supplement 37 · standardAP
2015-04-23Manufacturing (CMC) · Supplement 38 · standardAP
2015-04-22Manufacturing (CMC) · Supplement 39 · standardAP
2011-11-04Labeling · Supplement 34 · standardAP
2011-07-28Labeling · Supplement 33 · standard — Letter ↗AP
2009-12-17Efficacy · Supplement 29 · standard — Review ↗AP
2009-03-03Labeling · Supplement 14 · standard — Letter ↗AP
2008-11-13Labeling · Supplement 27 · standard — Label ↗AP
2008-06-20Labeling · Supplement 22 · standard — Letter ↗AP
2006-12-08Labeling · Supplement 15 · standard — Label ↗AP
2006-12-08Labeling · Supplement 8 · standard — Letter ↗AP
2006-09-20Labeling · Supplement 7 · standard — Letter ↗AP
2004-08-23Labeling · Supplement 1 · standard — Letter ↗AP
2004-01-30Type 1 - New Molecular Entity · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

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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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