← FDA DRUG APPROVALS

FDA NDA · NDA020548

FLOVENT

Sponsor: GLAXOSMITHKLINE

APPLICATION
NDA020548
TYPE
NDA
ORIGINAL APPROVAL
1996-03-27
LATEST ACTION
2004-03-26
ROUTE
INHALATION
DOSAGE FORM
AEROSOL, METERED
MARKETING STATUS
Discontinued

Products

FLOVENTDiscontinued
FLUTICASONE PROPIONATE 0.11MG/INH · AEROSOL, METERED · INHALATION
FLOVENTDiscontinued
FLUTICASONE PROPIONATE 0.22MG/INH · AEROSOL, METERED · INHALATION
FLOVENTDiscontinued
FLUTICASONE PROPIONATE 0.044MG/INH · AEROSOL, METERED · INHALATION

Approval history

2004-03-26Labeling · Supplement 20 · standard — Label ↗AP
2003-10-08Labeling · Supplement 19 · standard — Label ↗AP
2003-06-20Labeling · Supplement 16 · standard — Letter ↗AP
2001-08-15Manufacturing (CMC) · Supplement 14 · standardAP
2000-05-17Manufacturing (CMC) · Supplement 12 · standardAP
1998-12-22Labeling · Supplement 8 · standard — Review ↗AP
1998-11-04Manufacturing (CMC) · Supplement 7 · standardAP
1998-07-31Manufacturing (CMC) · Supplement 6 · standardAP
1998-04-13Manufacturing (CMC) · Supplement 5 · standardAP
1998-02-18Manufacturing (CMC) · Supplement 4 · standardAP
1997-10-14Labeling · Supplement 3 · standardAP
1996-06-05Manufacturing (CMC) · Supplement 2 · standardAP
1996-05-07Manufacturing (CMC) · Supplement 1 · standardAP
1996-03-27Type 3 - New Dosage Form · Original · standard — Pediatric Written Request ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →