LUPIN LTD FDA Approval ANDA 207393

ANDA 207393

LUPIN LTD

FDA Drug Application

Application #207393

Application Sponsors

ANDA 207393LUPIN LTD

Marketing Status

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

Application Products

001CAPSULE;ORAL18MG0DICLOFENACDICLOFENAC
002CAPSULE;ORAL35MG0DICLOFENACDICLOFENAC

FDA Submissions

UNKNOWN; ORIG1TA2016-12-02STANDARD

Submissions Property Types

ORIG1Null31

CDER Filings

LUPIN LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207393
            [companyName] => LUPIN LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"DICLOFENAC","activeIngredients":"DICLOFENAC","strength":"18MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"DICLOFENAC","activeIngredients":"DICLOFENAC","strength":"35MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/02\/2016","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2016-12-02
        )

)

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