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FDA NDA · NDA202450

TUDORZA PRESSAIR

aclidinium bromide

Sponsor: AZURITY

APPLICATION
NDA202450
TYPE
NDA
ORIGINAL APPROVAL
2012-07-23
LATEST ACTION
2019-03-29
ROUTE
RESPIRATORY (INHALATION), INHALATION
DOSAGE FORM
POWDER, METERED
MARKETING STATUS
Prescription

Products

TUDORZA PRESSAIR · ReferencePrescription
ACLIDINIUM BROMIDE 0.4MG/INH · POWDER, METERED · INHALATION

Approval history

2019-03-29Efficacy · Supplement 12 · standard — Label ↗AP
2018-11-09Labeling · Supplement 11 · standard — Label ↗AP
2016-03-24Manufacturing (CMC) · Supplement 7 · standardAP
2016-03-16Labeling · Supplement 6 · standard — Label ↗AP
2015-04-03Labeling · Supplement 5 · standard — Label ↗AP
2014-10-30Labeling · Supplement 3 · standard — Letter ↗AP
2014-10-23Manufacturing (CMC) · Supplement 4 · standardAP
2014-07-17Labeling · Supplement 2 · standard — Letter ↗AP
2013-05-03Manufacturing (CMC) · Supplement 1 · standardAP
2012-07-23Type 1 - New Molecular Entity · Original · standard — Review ↗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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