APPLICATION
ANDA207628
TYPE
ANDA
ORIGINAL APPROVAL
2017-01-31
LATEST ACTION
2020-02-07
ROUTE
RESPIRATORY (INHALATION), INHALATION
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
LEVALBUTEROL HYDROCHLORIDEPrescription
LEVALBUTEROL HYDROCHLORIDE EQ 0.25% BASE · SOLUTION · INHALATION
Approval history
2020-02-07Labeling · Supplement 4 · standardAP
2017-01-31UNKNOWN · 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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