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FDA NDA · NDA020236

SEREVENT

Sponsor: GLAXOSMITHKLINE

APPLICATION
NDA020236
TYPE
NDA
ORIGINAL APPROVAL
1994-02-04
LATEST ACTION
2004-09-28
ROUTE
INHALATION
DOSAGE FORM
AEROSOL, METERED
MARKETING STATUS
Discontinued

Products

SEREVENTDiscontinued
SALMETEROL XINAFOATE EQ 0.021MG BASE/INH · AEROSOL, METERED · INHALATION

Approval history

2004-09-28Labeling · Supplement 30 · priority — Letter ↗AP
2003-08-11Labeling · Supplement 28 · priority — Label ↗AP
2001-10-16Manufacturing (CMC) · Supplement 25 · priorityAP
2001-05-17Labeling · Supplement 23 · priorityAP
2000-06-29Efficacy · Supplement 19 · priorityAP
2000-06-15Manufacturing (CMC) · Supplement 21 · priorityAP
2000-02-25Labeling · Supplement 18 · priorityAP
1998-12-24Labeling · Supplement 17 · priority — Review ↗AP
1998-05-11Labeling · Supplement 16 · priorityAP
1998-02-05Efficacy · Supplement 15 · priorityAP
1997-11-26Labeling · Supplement 14 · priorityAP
1996-10-15Manufacturing (CMC) · Supplement 3 · priorityAP
1996-08-06Manufacturing (CMC) · Supplement 13 · priorityAP
1996-07-09Labeling · Supplement 1 · priorityAP
1995-11-13Manufacturing (CMC) · Supplement 11 · priorityAP
1995-07-19Manufacturing (CMC) · Supplement 10 · priority — Review ↗AP
1995-03-14Manufacturing (CMC) · Supplement 8 · priorityAP
1994-12-23Labeling · Supplement 9 · priorityAP
1994-12-23Manufacturing (CMC) · Supplement 6 · priorityAP
1994-02-04Type 1 - New Molecular Entity · Original · priority — Other Important Information from FDA ↗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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