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FDA NDA · NDA021949

PULMICORT FLEXHALER

budesonide

Sponsor: CHEPLAPHARM

APPLICATION
NDA021949
TYPE
NDA
ORIGINAL APPROVAL
2006-07-12
LATEST ACTION
2019-09-06
ROUTE
RESPIRATORY (INHALATION), INHALATION
DOSAGE FORM
POWDER, METERED
MARKETING STATUS
Prescription

Products

PULMICORT FLEXHALER · ReferencePrescription
BUDESONIDE 0.08MG/INH · POWDER, METERED · INHALATION
PULMICORT FLEXHALER · ReferencePrescription
BUDESONIDE 0.16MG/INH · POWDER, METERED · INHALATION

Approval history

2019-09-06Labeling · Supplement 13 · standard — Letter ↗AP
2016-06-17Manufacturing (CMC) · Supplement 11 · standardAP
2015-07-16Manufacturing (CMC) · Supplement 10 · standardAP
2010-07-02Labeling · Supplement 6 · standard — Letter ↗AP
2008-06-13Labeling · Supplement 4 · standard — Letter ↗AP
2008-04-11Labeling · Supplement 3 · standard — Letter ↗AP
2007-06-21Labeling · Supplement 2 · standard — Letter ↗AP
2007-02-16Labeling · Supplement 1 · standard — Letter ↗AP
2006-07-12Type 5 - New Formulation or New Manufacturer · Original · standard — Label ↗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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