APPLICATION
ANDA074543
TYPE
ANDA
ORIGINAL APPROVAL
1998-01-15
LATEST ACTION
2017-03-31
ROUTE
INHALATION
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
ALBUTEROL SULFATEPrescription
ALBUTEROL SULFATE EQ 0.5% BASE · SOLUTION · INHALATION
Approval history
2017-03-31Labeling · Supplement 7 · standardAP
2010-04-30Labeling · Supplement 4AP
2009-08-31Labeling · Supplement 3AP
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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