← FDA DRUG APPROVALS

FDA NDA · NDA020833

FLUTICASONE PROPIONATE DISKUS

fluticasone propionate

Sponsor: GLAXO GRP LTD

APPLICATION
NDA020833
TYPE
NDA
ORIGINAL APPROVAL
2000-09-29
LATEST ACTION
2019-01-07
ROUTE
RESPIRATORY (INHALATION), INHALATION
DOSAGE FORM
POWDER
MARKETING STATUS
Prescription

Products

FLOVENT DISKUS 250 · ReferencePrescription
FLUTICASONE PROPIONATE 0.25MG/INH · POWDER · INHALATION
FLOVENT DISKUS 50 · ReferencePrescription
FLUTICASONE PROPIONATE 0.05MG/INH · POWDER · INHALATION
FLOVENT DISKUS 100 · ReferencePrescription
FLUTICASONE PROPIONATE 0.1MG/INH · POWDER · INHALATION

Approval history

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 — Label ↗AP
2014-11-13Labeling · Supplement 30 · standard — Letter ↗AP
2014-06-17Manufacturing (CMC) · Supplement 29 · standardAP
2014-04-14Labeling · Supplement 28 · standard — Label ↗AP
2013-06-19Manufacturing (CMC) · Supplement 27 · standardAP
2012-12-05Manufacturing (CMC) · Supplement 26 · standardAP
2010-05-03Labeling · Supplement 21 · standard — Letter ↗AP
2005-09-14Labeling · Supplement 15 · standard — Label ↗AP
2005-07-31Labeling · Supplement 14 · standard — Letter ↗AP
2004-12-17Manufacturing (CMC) · Supplement 12 · standard — Label ↗AP
2002-11-01Labeling · Supplement 8 · standard — Letter ↗AP
2002-11-01Labeling · Supplement 2 · standard — Letter ↗AP
2002-05-15Manufacturing (CMC) · Supplement 6 · standardAP
2002-04-05Manufacturing (CMC) · Supplement 1 · standardAP
2000-09-29Type 3 - New Dosage Form · 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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