← FDA DRUG APPROVALS

FDA NDA · NDA021077

ADVAIR DISKUS

fluticasone propionate and salmeterol

Sponsor: GLAXO GRP LTD

APPLICATION
NDA021077
TYPE
NDA
ORIGINAL APPROVAL
2000-08-24
LATEST ACTION
2019-01-07
ROUTE
RESPIRATORY (INHALATION), INHALATION
DOSAGE FORM
POWDER
MARKETING STATUS
Prescription

Products

ADVAIR DISKUS 500/50 · ReferencePrescription
FLUTICASONE PROPIONATE 0.5MG/INH, SALMETEROL XINAFOATE EQ 0.05MG BASE/INH · POWDER · INHALATION
ADVAIR DISKUS 100/50 · ReferencePrescription
FLUTICASONE PROPIONATE 0.1MG/INH, SALMETEROL XINAFOATE EQ 0.05MG BASE/INH · POWDER · INHALATION
ADVAIR DISKUS 250/50 · ReferencePrescription
FLUTICASONE PROPIONATE 0.25MG/INH, SALMETEROL XINAFOATE EQ 0.05MG BASE/INH · POWDER · INHALATION

Approval history

2019-01-07Labeling · Supplement 61 · standard — Label ↗AP
2017-12-20Efficacy · Supplement 56 · standard — Label ↗AP
2017-12-20Efficacy · Supplement 57 · standard — Label ↗AP
2017-02-28Labeling · Supplement 58 · standard — Letter ↗AP
2016-04-29Labeling · Supplement 54 · standard — Other ↗AP
2014-11-13Labeling · Supplement 53 · standard — Letter ↗AP
2014-06-17Manufacturing (CMC) · Supplement 52 · standard — Review ↗AP
2014-04-14Labeling · Supplement 51 · standard — Review ↗AP
2013-06-19Manufacturing (CMC) · Supplement 50 · standard — Review ↗AP
2012-08-09Labeling · Supplement 48 · standardAP
2012-08-09REMS · Supplement 49 — Letter ↗AP
2011-06-27REMS · Supplement 47 — Letter ↗AP
2011-05-10REMS · Supplement 46 — Letter ↗AP
2011-01-04REMS · Supplement 41 — Letter ↗AP
2010-06-25Labeling · Supplement 42 · 901 order — Letter ↗AP
2009-03-31Efficacy · Supplement 36 · unknown — Letter ↗AP
2008-04-30Efficacy · Supplement 29 · unknown — Summary Review ↗AP
2007-02-23Labeling · Supplement 27 · standard — Label ↗AP
2006-09-27Labeling · Supplement 26 · standard — Label ↗AP
2006-03-02Labeling · Supplement 28 · standard — Label ↗AP
2004-09-28Labeling · Supplement 22 · standard — Letter ↗AP
2004-04-21Efficacy · Supplement 17 · unknown — Review ↗AP
2003-11-17Efficacy · Supplement 3 · standard — Review ↗AP
2003-08-11Labeling · Supplement 19 · standard — Label ↗AP
2002-08-21Labeling · Supplement 8 · standard — Letter ↗AP
2002-05-17Manufacturing (CMC) · Supplement 9 · standardAP
2001-10-16Manufacturing (CMC) · Supplement 4 · standardAP
2000-12-22Manufacturing (CMC) · Supplement 1 · standardAP
2000-08-24Type 4 - New Combination · 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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