LUPIN LTD FDA Approval ANDA 206890

ANDA 206890

LUPIN LTD

FDA Drug Application

Application #206890

Application Sponsors

ANDA 206890LUPIN LTD

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004
Prescription005
Prescription006
Prescription007

Application Products

001TABLET;ORAL1MG0ILOPERIDONEILOPERIDONE
002TABLET;ORAL2MG0ILOPERIDONEILOPERIDONE
003TABLET;ORAL4MG0ILOPERIDONEILOPERIDONE
004TABLET;ORAL6MG0ILOPERIDONEILOPERIDONE
005TABLET;ORAL8MG0ILOPERIDONEILOPERIDONE
006TABLET;ORAL10MG0ILOPERIDONEILOPERIDONE
007TABLET;ORAL12MG0ILOPERIDONEILOPERIDONE

FDA Submissions

UNKNOWN; ORIG1AP2022-05-05STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB
004PrescriptionAB
005PrescriptionAB
006PrescriptionAB
007PrescriptionAB

CDER Filings

LUPIN LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206890
            [companyName] => LUPIN LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"ILOPERIDONE","activeIngredients":"ILOPERIDONE","strength":"1MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ILOPERIDONE","activeIngredients":"ILOPERIDONE","strength":"2MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ILOPERIDONE","activeIngredients":"ILOPERIDONE","strength":"4MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ILOPERIDONE","activeIngredients":"ILOPERIDONE","strength":"6MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ILOPERIDONE","activeIngredients":"ILOPERIDONE","strength":"8MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ILOPERIDONE","activeIngredients":"ILOPERIDONE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ILOPERIDONE","activeIngredients":"ILOPERIDONE","strength":"12MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/05\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-05-05
        )

)

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