CELLTRION FDA Approval ANDA 078982

ANDA 078982

CELLTRION

FDA Drug Application

Application #078982

Application Sponsors

ANDA 078982CELLTRION

Marketing Status

Discontinued001
Discontinued002
Discontinued003
Discontinued004

Application Products

001TABLET;ORAL25MG0LAMOTRIGINELAMOTRIGINE
002TABLET;ORAL100MG0LAMOTRIGINELAMOTRIGINE
003TABLET;ORAL150MG0LAMOTRIGINELAMOTRIGINE
004TABLET;ORAL200MG0LAMOTRIGINELAMOTRIGINE

FDA Submissions

ORIG1AP2009-01-27
LABELING; LabelingSUPPL2AP2016-10-17STANDARD
LABELING; LabelingSUPPL3AP2022-08-22STANDARD
LABELING; LabelingSUPPL4AP2022-08-22STANDARD
LABELING; LabelingSUPPL5AP2022-08-22STANDARD

Submissions Property Types

SUPPL2Null15
SUPPL3Null7
SUPPL4Null7
SUPPL5Null7

CDER Filings

CELLTRION
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78982
            [companyName] => CELLTRION
            [docInserts] => ["",""]
            [products] => [{"drugName":"LAMOTRIGINE","activeIngredients":"LAMOTRIGINE","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"LAMOTRIGINE","activeIngredients":"LAMOTRIGINE","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"LAMOTRIGINE","activeIngredients":"LAMOTRIGINE","strength":"150MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"LAMOTRIGINE","activeIngredients":"LAMOTRIGINE","strength":"200MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"LAMOTRIGINE","submission":"LAMOTRIGINE","actionType":"25MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"LAMOTRIGINE","submission":"LAMOTRIGINE","actionType":"100MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"LAMOTRIGINE","submission":"LAMOTRIGINE","actionType":"150MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"LAMOTRIGINE","submission":"LAMOTRIGINE","actionType":"200MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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