APPLICATION
ANDA076355
TYPE
ANDA
ORIGINAL APPROVAL
2004-06-28
LATEST ACTION
2011-09-13
ROUTE
RESPIRATORY (INHALATION), INHALATION
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
ALBUTEROL SULFATEPrescription
ALBUTEROL SULFATE EQ 0.042% BASE · SOLUTION · INHALATION
ALBUTEROL SULFATEPrescription
ALBUTEROL SULFATE EQ 0.021% BASE · SOLUTION · INHALATION
Approval history
2011-09-13Labeling · Supplement 12AP
2010-03-31Labeling · Supplement 7AP
2007-03-29Labeling · Supplement 4AP
2005-03-22Labeling · Supplement 1AP
2004-06-28OriginalAP
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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