YILING FDA Approval ANDA 213949

ANDA 213949

YILING

FDA Drug Application

Application #213949

Application Sponsors

ANDA 213949YILING

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004
Prescription005
Prescription006

Application Products

001TABLET, EXTENDED RELEASE;ORAL25MG0LAMOTRIGINELAMOTRIGINE
002TABLET, EXTENDED RELEASE;ORAL50MG0LAMOTRIGINELAMOTRIGINE
003TABLET, EXTENDED RELEASE;ORAL100MG0LAMOTRIGINELAMOTRIGINE
004TABLET, EXTENDED RELEASE;ORAL200MG0LAMOTRIGINELAMOTRIGINE
005TABLET, EXTENDED RELEASE;ORAL250MG0LAMOTRIGINELAMOTRIGINE
006TABLET, EXTENDED RELEASE;ORAL300MG0LAMOTRIGINELAMOTRIGINE

FDA Submissions

UNKNOWN; ORIG1AP2021-12-08STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

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

CDER Filings

YILING
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213949
            [companyName] => YILING
            [docInserts] => ["",""]
            [products] => [{"drugName":"LAMOTRIGINE","activeIngredients":"LAMOTRIGINE","strength":"25MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LAMOTRIGINE","activeIngredients":"LAMOTRIGINE","strength":"50MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LAMOTRIGINE","activeIngredients":"LAMOTRIGINE","strength":"100MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LAMOTRIGINE","activeIngredients":"LAMOTRIGINE","strength":"200MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LAMOTRIGINE","activeIngredients":"LAMOTRIGINE","strength":"250MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LAMOTRIGINE","activeIngredients":"LAMOTRIGINE","strength":"300MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/08\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-12-08
        )

)

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