APPLICATION
ANDA207625
TYPE
ANDA
ORIGINAL APPROVAL
2016-12-30
LATEST ACTION
2020-02-06
ROUTE
RESPIRATORY (INHALATION), INHALATION
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
LEVALBUTEROL HYDROCHLORIDEPrescription
LEVALBUTEROL HYDROCHLORIDE EQ 0.021% BASE · SOLUTION · INHALATION
LEVALBUTEROL HYDROCHLORIDEPrescription
LEVALBUTEROL HYDROCHLORIDE EQ 0.042% BASE · SOLUTION · INHALATION
LEVALBUTEROL HYDROCHLORIDEPrescription
LEVALBUTEROL HYDROCHLORIDE EQ 0.0103% BASE · SOLUTION · INHALATION
Approval history
2020-02-06Labeling · Supplement 4 · standardAP
2016-12-30UNKNOWN · Original · standardAP
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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