ZYDUS PHARMS USA INC FDA Approval ANDA 211818

ANDA 211818

ZYDUS PHARMS USA INC

FDA Drug Application

Application #211818

Application Sponsors

ANDA 211818ZYDUS PHARMS USA INC

Marketing Status

None (Tentative Approval)001
None (Tentative Approval)002
None (Tentative Approval)003

Application Products

002CAPSULE;ORAL200MG0DROXIDOPADROXIDOPA
003CAPSULE;ORAL300MG0DROXIDOPADROXIDOPA

FDA Submissions

UNKNOWN; ORIG1TA2020-05-14STANDARD

Submissions Property Types

ORIG1Null31

CDER Filings

ZYDUS PHARMS USA INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211818
            [companyName] => ZYDUS PHARMS USA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"DROXIDOPA","activeIngredients":"DROXIDOPA","strength":"100MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"DROXIDOPA","activeIngredients":"DROXIDOPA","strength":"200MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"DROXIDOPA","activeIngredients":"DROXIDOPA","strength":"300MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/14\/2020","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-05-14
        )

)

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