APPLICATION
ANDA077756
TYPE
ANDA
ORIGINAL APPROVAL
2008-04-09
LATEST ACTION
2017-12-27
ROUTE
INHALATION
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
LEVALBUTEROL HYDROCHLORIDEPrescription
LEVALBUTEROL HYDROCHLORIDE EQ 0.0103% BASE · SOLUTION · INHALATION
LEVALBUTEROL HYDROCHLORIDEPrescription
LEVALBUTEROL HYDROCHLORIDE EQ 0.021% BASE · SOLUTION · INHALATION
LEVALBUTEROL HYDROCHLORIDEPrescription
LEVALBUTEROL HYDROCHLORIDE EQ 0.042% BASE · SOLUTION · INHALATION
Approval history
2017-12-27Labeling · Supplement 3 · standardAP
2008-04-09OriginalAP
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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