APPLICATION
ANDA073272
TYPE
ANDA
ORIGINAL APPROVAL
1995-12-28
LATEST ACTION
2008-04-18
ROUTE
INHALATION
DOSAGE FORM
AEROSOL, METERED
MARKETING STATUS
Discontinued
Products
ALBUTEROLDiscontinued
ALBUTEROL 0.09MG/INH · AEROSOL, METERED · INHALATION
Approval history
2008-04-18Labeling · Supplement 8AP
2001-10-22Manufacturing (CMC) · Supplement 13AP
2000-04-28Labeling · Supplement 10AP
1998-08-18Manufacturing (CMC) · Supplement 7AP
1997-12-17Manufacturing (CMC) · Supplement 6AP
1997-12-15Manufacturing (CMC) · Supplement 5AP
1997-09-22Manufacturing (CMC) · Supplement 4AP
1997-01-16Manufacturing (CMC) · Supplement 3AP
1997-01-16Manufacturing (CMC) · Supplement 2AP
1996-07-22Labeling · Supplement 1AP
1995-12-28OriginalAP
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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