ZYDUS PHARMS FDA Approval ANDA 215577

ANDA 215577

ZYDUS PHARMS

FDA Drug Application

Application #215577

Application Sponsors

ANDA 215577ZYDUS PHARMS

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

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

FDA Submissions

UNKNOWN; ORIG1AP2022-08-26STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB

CDER Filings

ZYDUS PHARMS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215577
            [companyName] => ZYDUS PHARMS
            [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":"08\/26\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-08-26
        )

)

© 2022 FDA.report
This site is not affiliated with or endorsed by the FDA.