APPLICATION
ANDA074072
TYPE
ANDA
ORIGINAL APPROVAL
1996-08-01
LATEST ACTION
2001-08-23
ROUTE
INHALATION
DOSAGE FORM
AEROSOL, METERED
MARKETING STATUS
Discontinued
Products
ALBUTEROLDiscontinued
ALBUTEROL 0.09MG/INH · AEROSOL, METERED · INHALATION
Approval history
2001-08-23Manufacturing (CMC) · Supplement 9AP
2000-12-20Manufacturing (CMC) · Supplement 8AP
2000-01-14Manufacturing (CMC) · Supplement 2AP
1999-09-13Labeling · Supplement 7AP
1999-07-13Labeling · Supplement 6AP
1998-12-03Labeling · Supplement 5AP
1998-05-08Labeling · Supplement 4AP
1998-01-20Manufacturing (CMC) · Supplement 3AP
1997-03-27Labeling · Supplement 1AP
1996-08-01OriginalAP
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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