LOTUS PHARM CO LTD FDA Approval ANDA 090906

ANDA 090906

LOTUS PHARM CO LTD

FDA Drug Application

Application #090906

Documents

Letter2021-12-20

Application Sponsors

ANDA 090906LOTUS PHARM CO LTD

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004

Application Products

001TABLET;ORAL500MG0LEVETIRACETAMLEVETIRACETAM
002TABLET;ORAL250MG0LEVETIRACETAMLEVETIRACETAM
003TABLET;ORAL750MG0LEVETIRACETAMLEVETIRACETAM
004TABLET;ORAL1GM0LEVETIRACETAMLEVETIRACETAM

FDA Submissions

ORIG1AP2010-11-05
MANUF (CMC); Manufacturing (CMC)SUPPL2AP2016-10-31
LABELING; LabelingSUPPL5AP2015-01-16STANDARD
LABELING; LabelingSUPPL6AP2015-11-24STANDARD
LABELING; LabelingSUPPL7AP2015-12-26STANDARD

Submissions Property Types

ORIG1Null7
SUPPL2Null7
SUPPL5Null15
SUPPL6Null7
SUPPL7Null7

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB
004PrescriptionAB

CDER Filings

LOTUS PHARM CO LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90906
            [companyName] => LOTUS PHARM CO LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"LEVETIRACETAM","activeIngredients":"LEVETIRACETAM","strength":"500MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LEVETIRACETAM","activeIngredients":"LEVETIRACETAM","strength":"250MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LEVETIRACETAM","activeIngredients":"LEVETIRACETAM","strength":"750MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LEVETIRACETAM","activeIngredients":"LEVETIRACETAM","strength":"1GM","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"LEVETIRACETAM","submission":"LEVETIRACETAM","actionType":"500MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"LEVETIRACETAM","submission":"LEVETIRACETAM","actionType":"250MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"LEVETIRACETAM","submission":"LEVETIRACETAM","actionType":"750MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"LEVETIRACETAM","submission":"LEVETIRACETAM","actionType":"1GM","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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