APPLICATION
ANDA075358
TYPE
ANDA
ORIGINAL APPROVAL
2000-03-29
LATEST ACTION
2004-09-21
ROUTE
INHALATION
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued
Products
ALBUTEROL SULFATEDiscontinued
ALBUTEROL SULFATE EQ 0.083% BASE · SOLUTION · INHALATION
Approval history
2004-09-21Labeling · Supplement 14AP
2004-05-14Labeling · Supplement 12AP
2002-07-23Manufacturing (CMC) · Supplement 6AP
2001-11-27Manufacturing (CMC) · Supplement 5AP
2001-09-21Manufacturing (CMC) · Supplement 4AP
2001-01-22Labeling · Supplement 3AP
2001-01-22Manufacturing (CMC) · Supplement 1AP
2001-01-22Manufacturing (CMC) · Supplement 2AP
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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