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FDA NDA · NDA021433

FLUTICASONE PROPIONATE HFA

fluticasone propionate

Sponsor: GLAXO GRP LTD

APPLICATION
NDA021433
TYPE
NDA
ORIGINAL APPROVAL
2004-05-14
LATEST ACTION
2021-08-18
ROUTE
RESPIRATORY (INHALATION), INHALATION
DOSAGE FORM
AEROSOL, METERED
MARKETING STATUS
Prescription

Products

FLOVENT HFA · ReferencePrescription
FLUTICASONE PROPIONATE 0.044MG/INH · AEROSOL, METERED · INHALATION
FLOVENT HFA · ReferencePrescription
FLUTICASONE PROPIONATE 0.22MG/INH · AEROSOL, METERED · INHALATION
FLOVENT HFA · ReferencePrescription
FLUTICASONE PROPIONATE 0.11MG/INH · AEROSOL, METERED · INHALATION

Approval history

2021-08-18Labeling · Supplement 40 · standard — Letter ↗AP
2019-01-07Labeling · Supplement 34 · standard — Label ↗AP
2017-07-19Labeling · Supplement 33 · standard — Label ↗AP
2016-10-05Labeling · Supplement 32 · standard — Letter ↗AP
2016-07-28Labeling · Supplement 31 · standard — Letter ↗AP
2016-05-20Manufacturing (CMC) · Supplement 30 · standardAP
2016-01-06Manufacturing (CMC) · Supplement 29 · standardAP
2014-12-10Labeling · Supplement 26 · standard — Label ↗AP
2014-11-14Labeling · Supplement 25 · standard — Letter ↗AP
2014-06-17Manufacturing (CMC) · Supplement 23 · standardAP
2014-06-17Manufacturing (CMC) · Supplement 24 · standardAP
2013-07-18Manufacturing (CMC) · Supplement 22 · standard — Label ↗AP
2013-06-19Manufacturing (CMC) · Supplement 21 · standardAP
2011-07-28Labeling · Supplement 19 · standard — Label ↗AP
2010-11-03Labeling · Supplement 15 · standard — Label ↗AP
2008-07-01Labeling · Supplement 11 · standard — Label ↗AP
2006-10-25Manufacturing (CMC) · Supplement 6 · standard — Letter ↗AP
2006-02-28Efficacy · Supplement 4 · unknown — Label ↗AP
2005-12-21Labeling · Supplement 5 · standard — Label ↗AP
2004-05-14Type 3 - New Dosage Form · Original · standard — Label ↗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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