SMITH AND NEPHEW FDA Approval ANDA 088518

ANDA 088518

SMITH AND NEPHEW

FDA Drug Application

Application #088518

Application Sponsors

ANDA 088518SMITH AND NEPHEW

Marketing Status

Discontinued001

Application Products

001INJECTABLE;INJECTION20MG/ML0HYDRALAZINE HYDROCHLORIDEHYDRALAZINE HYDROCHLORIDE

CDER Filings

SMITH AND NEPHEW
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 88518
            [companyName] => SMITH AND NEPHEW
            [docInserts] => ["",""]
            [products] => [{"drugName":"HYDRALAZINE HYDROCHLORIDE","activeIngredients":"HYDRALAZINE HYDROCHLORIDE","strength":"20MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"HYDRALAZINE HYDROCHLORIDE","submission":"HYDRALAZINE HYDROCHLORIDE","actionType":"20MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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