AJANTA PHARMA LTD FDA Approval ANDA 205792

ANDA 205792

AJANTA PHARMA LTD

FDA Drug Application

Application #205792

Application Sponsors

ANDA 205792AJANTA PHARMA LTD

Marketing Status

Prescription001

Application Products

001TABLET;ORAL200MG0ENTACAPONEENTACAPONE

FDA Submissions

UNKNOWN; ORIG1AP2017-08-31STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB

CDER Filings

AJANTA PHARMA LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205792
            [companyName] => AJANTA PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"ENTACAPONE","activeIngredients":"ENTACAPONE","strength":"200MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/31\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-08-31
        )

)

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