APPLICATION
ANDA072652
TYPE
ANDA
ORIGINAL APPROVAL
1992-02-21
LATEST ACTION
2012-02-16
ROUTE
INHALATION
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued
Products
ALBUTEROL SULFATEDiscontinued
ALBUTEROL SULFATE EQ 0.083% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SOLUTION · INHALATION
Approval history
2012-02-16Labeling · Supplement 43AP
2011-12-08Labeling · Supplement 47AP
2004-05-26Labeling · Supplement 27AP
2004-04-01Labeling · Supplement 24AP
2002-12-09Manufacturing (CMC) · Supplement 19AP
2002-12-09Manufacturing (CMC) · Supplement 21AP
2001-01-31Manufacturing (CMC) · Supplement 18AP
2000-12-20Manufacturing (CMC) · Supplement 17AP
2000-06-23Manufacturing (CMC) · Supplement 15AP
2000-02-29Manufacturing (CMC) · Supplement 14AP
1999-11-17Labeling · Supplement 16AP
1999-04-14Labeling · Supplement 12AP
1997-01-08Manufacturing (CMC) · Supplement 11AP
1997-01-08Manufacturing (CMC) · Supplement 10AP
1996-04-24Manufacturing (CMC) · Supplement 9AP
1994-11-30Labeling · Supplement 5AP
1994-09-09Labeling · Supplement 8AP
1993-05-04Manufacturing (CMC) · Supplement 4AP
1993-03-30Labeling · Supplement 2AP
1993-03-30Labeling · Supplement 3AP
1992-10-22Labeling · Supplement 1AP
1992-02-21OriginalAP
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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