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FDA NDA · NDA021254

ADVAIR HFA

fluticasone propionate and salmeterol xinafoate

Sponsor: GLAXO GRP LTD

APPLICATION
NDA021254
TYPE
NDA
ORIGINAL APPROVAL
2006-06-08
LATEST ACTION
2021-08-18
ROUTE
RESPIRATORY (INHALATION), INHALATION
DOSAGE FORM
AEROSOL, METERED
MARKETING STATUS
Prescription

Products

ADVAIR HFA · ReferencePrescription
FLUTICASONE PROPIONATE 0.115MG/INH, SALMETEROL XINAFOATE EQ 0.021MG BASE/INH · AEROSOL, METERED · INHALATION
ADVAIR HFA · ReferencePrescription
FLUTICASONE PROPIONATE 0.23MG/INH, SALMETEROL XINAFOATE EQ 0.021MG BASE/INH · AEROSOL, METERED · INHALATION
ADVAIR HFA · ReferencePrescription
FLUTICASONE PROPIONATE 0.045MG/INH, SALMETEROL XINAFOATE EQ 0.021MG BASE/INH · AEROSOL, METERED · INHALATION

Approval history

2021-08-18Labeling · Supplement 36 · standard — Letter ↗AP
2019-01-07Labeling · Supplement 28 · standard — Label ↗AP
2017-12-20Labeling · Supplement 27 · standard — Label ↗AP
2017-02-28Labeling · Supplement 26 · standard — Letter ↗AP
2014-12-10Labeling · Supplement 24 · standard — Letter ↗AP
2014-11-13Labeling · Supplement 23 · standard — Label ↗AP
2014-06-17Manufacturing (CMC) · Supplement 22 · standardAP
2014-06-17Manufacturing (CMC) · Supplement 21 · standardAP
2013-06-19Manufacturing (CMC) · Supplement 20 · standardAP
2012-12-19Efficacy · Supplement 9 · standard — Pediatric Medical Review ↗AP
2012-08-09Labeling · Supplement 18 · standardAP
2012-08-09REMS · Supplement 19 — Letter ↗AP
2011-06-27REMS · Supplement 16 — Letter ↗AP
2011-05-10REMS · Supplement 15 — Letter ↗AP
2011-01-04REMS · Supplement 12 — Letter ↗AP
2010-06-25Labeling · Supplement 13 · 901 order — Label ↗AP
2009-09-15Labeling · Supplement 7 · standard — Letter ↗AP
2008-07-31Manufacturing (CMC) · Supplement 4 — Letter ↗AP
2008-03-20Labeling · Supplement 3 · standard — Label ↗AP
2006-06-08Type 3 - New Dosage Form · Original · standard — Letter ↗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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