EUROHLTH INTL SARL FDA Approval ANDA 083183

ANDA 083183

EUROHLTH INTL SARL

FDA Drug Application

Application #083183

Application Sponsors

ANDA 083183EUROHLTH INTL SARL

Marketing Status

Discontinued001

Application Products

001INJECTABLE;INJECTION50MG/ML0DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDE

FDA Submissions

ORIG1AP1973-10-12

CDER Filings

EUROHLTH INTL SARL
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 83183
            [companyName] => EUROHLTH INTL SARL
            [docInserts] => ["",""]
            [products] => [{"drugName":"DIPHENHYDRAMINE HYDROCHLORIDE","activeIngredients":"DIPHENHYDRAMINE HYDROCHLORIDE","strength":"50MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"DIPHENHYDRAMINE HYDROCHLORIDE","submission":"DIPHENHYDRAMINE HYDROCHLORIDE","actionType":"50MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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