SUN PHARM INDS LTD FDA Approval ANDA 211889

ANDA 211889

SUN PHARM INDS LTD

FDA Drug Application

Application #211889

Application Sponsors

ANDA 211889SUN PHARM INDS LTD

Marketing Status

None (Tentative Approval)001
Prescription002
Prescription003

Application Products

001TABLET, EXTENDED RELEASE;ORAL82.5MG0PREGABALINPREGABALIN
002TABLET, EXTENDED RELEASE;ORAL165MG0PREGABALINPREGABALIN
003TABLET, EXTENDED RELEASE;ORAL330MG0PREGABALINPREGABALIN

FDA Submissions

UNKNOWN; ORIG1TA2020-03-25STANDARD

Submissions Property Types

ORIG1Null31

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB

CDER Filings

SUN PHARM
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211889
            [companyName] => SUN PHARM
            [docInserts] => ["",""]
            [products] => [{"drugName":"PREGABALIN","activeIngredients":"PREGABALIN","strength":"82.5MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PREGABALIN","activeIngredients":"PREGABALIN","strength":"165MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PREGABALIN","activeIngredients":"PREGABALIN","strength":"330MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/13\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-04-13
        )

)

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