APPLICATION
ANDA077839
TYPE
ANDA
ORIGINAL APPROVAL
2008-12-16
LATEST ACTION
2013-01-28
ROUTE
RESPIRATORY (INHALATION), INHALATION
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
ALBUTEROL SULFATEPrescription
ALBUTEROL SULFATE EQ 0.083% BASE · SOLUTION · INHALATION
Approval history
2013-01-28Labeling · Supplement 13 · standardAP
2008-12-16OriginalAP
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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