UPSHER SMITH LABS FDA Approval ANDA 209251

ANDA 209251

UPSHER SMITH LABS

FDA Drug Application

Application #209251

Application Sponsors

ANDA 209251UPSHER SMITH LABS

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004

Application Products

001TABLET;ORAL10MG0HYDRALAZINE HYDROCHLORIDEHYDRALAZINE HYDROCHLORIDE
002TABLET;ORAL25MG0HYDRALAZINE HYDROCHLORIDEHYDRALAZINE HYDROCHLORIDE
003TABLET;ORAL50MG0HYDRALAZINE HYDROCHLORIDEHYDRALAZINE HYDROCHLORIDE
004TABLET;ORAL100MG0HYDRALAZINE HYDROCHLORIDEHYDRALAZINE HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2018-07-09STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAA
002PrescriptionAA
003PrescriptionAA
004PrescriptionAA

CDER Filings

UPSHER SMITH LABS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209251
            [companyName] => UPSHER SMITH LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"HYDRALAZINE HYDROCHLORIDE","activeIngredients":"HYDRALAZINE HYDROCHLORIDE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"HYDRALAZINE HYDROCHLORIDE","activeIngredients":"HYDRALAZINE HYDROCHLORIDE","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"HYDRALAZINE HYDROCHLORIDE","activeIngredients":"HYDRALAZINE HYDROCHLORIDE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"HYDRALAZINE HYDROCHLORIDE","activeIngredients":"HYDRALAZINE HYDROCHLORIDE","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/09\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-07-09
        )

)

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