ASTRAZENECA FDA Approval ANDA 089616

ANDA 089616

ASTRAZENECA

FDA Drug Application

Application #089616

Application Sponsors

ANDA 089616ASTRAZENECA

Marketing Status

Discontinued001

Application Products

001SOLUTION;INHALATION0.167%0ISOETHARINE HYDROCHLORIDEISOETHARINE HYDROCHLORIDE

FDA Submissions

ORIG1AP1991-06-13

CDER Filings

ASTRAZENECA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 89616
            [companyName] => ASTRAZENECA
            [docInserts] => ["",""]
            [products] => [{"drugName":"ISOETHARINE HYDROCHLORIDE","activeIngredients":"ISOETHARINE HYDROCHLORIDE","strength":"0.167%","dosageForm":"SOLUTION;INHALATION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ISOETHARINE HYDROCHLORIDE","submission":"ISOETHARINE HYDROCHLORIDE","actionType":"0.167%","submissionClassification":"SOLUTION;INHALATION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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