FdaApplication

NDA 020837

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Identifiers

Properties

PropertyValue
applicant_nameHIKMA PHARMS
application_typeNDA
approval_date1999-03-25

Products (4)

ProductActive ingredientStrengthDosage form
XOPENEXLEVALBUTEROL HYDROCHLORIDEEQ 0.0103% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION;INHALATION
XOPENEXLEVALBUTEROL HYDROCHLORIDEEQ 0.25% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION;INHALATION
XOPENEXLEVALBUTEROL HYDROCHLORIDEEQ 0.042% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION;INHALATION
XOPENEXLEVALBUTEROL HYDROCHLORIDEEQ 0.021% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION;INHALATION

4 products