LUPIN LTD FDA Approval ANDA 208643

ANDA 208643

LUPIN LTD

FDA Drug Application

Application #208643

Application Sponsors

ANDA 208643LUPIN LTD

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004

Application Products

001TABLET, EXTENDED RELEASE;ORAL1.5MG0PALIPERIDONEPALIPERIDONE
002TABLET, EXTENDED RELEASE;ORAL3MG0PALIPERIDONEPALIPERIDONE
003TABLET, EXTENDED RELEASE;ORAL6MG0PALIPERIDONEPALIPERIDONE
004TABLET, EXTENDED RELEASE;ORAL9MG0PALIPERIDONEPALIPERIDONE

FDA Submissions

UNKNOWN; ORIG1AP2022-06-29STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB
004PrescriptionAB

CDER Filings

LUPIN LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208643
            [companyName] => LUPIN LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"PALIPERIDONE","activeIngredients":"PALIPERIDONE","strength":"1.5MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PALIPERIDONE","activeIngredients":"PALIPERIDONE","strength":"3MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PALIPERIDONE","activeIngredients":"PALIPERIDONE","strength":"6MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PALIPERIDONE","activeIngredients":"PALIPERIDONE","strength":"9MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/29\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-06-29
        )

)

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