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FDA ANDA · ANDA077800

LEVALBUTEROL HYDROCHLORIDE

Sponsor: PHARMOBEDIENT

APPLICATION
ANDA077800
TYPE
ANDA
ORIGINAL APPROVAL
2013-03-15
LATEST ACTION
2016-10-03
ROUTE
INHALATION
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued

Products

LEVALBUTEROL HYDROCHLORIDEDiscontinued
LEVALBUTEROL HYDROCHLORIDE EQ 0.021% BASE · SOLUTION · INHALATION
LEVALBUTEROL HYDROCHLORIDEDiscontinued
LEVALBUTEROL HYDROCHLORIDE EQ 0.042% BASE · SOLUTION · INHALATION
LEVALBUTEROL HYDROCHLORIDEDiscontinued
LEVALBUTEROL HYDROCHLORIDE EQ 0.0103% BASE · SOLUTION · INHALATION

Approval history

2016-10-03Labeling · Supplement 2 · standardAP
2016-10-03Labeling · Supplement 1 · standardAP
2013-03-15OriginalAP
VIEW ON DRUGS@FDA ↗

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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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