FDA NDA · NDA020549

FLOVENT

Sponsor: GLAXOSMITHKLINE

APPLICATION

NDA020549

TYPE

NDA

ORIGINAL APPROVAL

1997-11-07

LATEST ACTION

2004-03-26

ROUTE

INHALATION

DOSAGE FORM

POWDER

MARKETING STATUS

Discontinued

Products

FLOVENTDiscontinued

FLUTICASONE PROPIONATE 0.088MG/INH · POWDER · INHALATION

FLOVENTDiscontinued

FLUTICASONE PROPIONATE 0.22MG/INH · POWDER · INHALATION

FLOVENTDiscontinued

FLUTICASONE PROPIONATE 0.044MG/INH · POWDER · INHALATION

2004-03-26Labeling · Supplement 16 · standard — Letter ↗AP

2003-10-08Labeling · Supplement 14 · standard — Label ↗AP

2003-06-20Labeling · Supplement 12 · standard — Label ↗AP

2001-08-27Manufacturing (CMC) · Supplement 10 · standardAP

2001-03-29Labeling · Supplement 8 · standardAP

2001-01-19Manufacturing (CMC) · Supplement 3 · standardAP

2000-11-01Manufacturing (CMC) · Supplement 9 · standardAP

2000-05-17Manufacturing (CMC) · Supplement 7 · standardAP

1999-07-19Labeling · Supplement 6 · standard — Review ↗AP

1999-04-23Manufacturing (CMC) · Supplement 4 · standardAP

1998-12-22Labeling · Supplement 2 · standard — Review ↗AP

1998-12-03Manufacturing (CMC) · Supplement 1 · standardAP

1997-11-07Type 3 - New Dosage Form · Original · standard — Review ↗AP

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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