TORRENT FDA Approval ANDA 203370

ANDA 203370

TORRENT

FDA Drug Application

Application #203370

Application Sponsors

ANDA 203370TORRENT

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004

Application Products

001TABLET, EXTENDED RELEASE;ORAL25MG0LAMOTRIGINELAMOTRIGINE
002TABLET, EXTENDED RELEASE;ORAL50MG0LAMOTRIGINELAMOTRIGINE
003TABLET, EXTENDED RELEASE;ORAL100MG0LAMOTRIGINELAMOTRIGINE
004TABLET, EXTENDED RELEASE;ORAL200MG0LAMOTRIGINELAMOTRIGINE

FDA Submissions

UNKNOWN; ORIG1AP2013-12-23
LABELING; LabelingSUPPL2AP2017-04-25STANDARD
LABELING; LabelingSUPPL3AP2017-04-25STANDARD
LABELING; LabelingSUPPL7AP2019-11-21STANDARD
LABELING; LabelingSUPPL9AP2019-11-21STANDARD
LABELING; LabelingSUPPL12AP2021-02-19STANDARD
LABELING; LabelingSUPPL13AP2021-11-09STANDARD

Submissions Property Types

ORIG1Null7
SUPPL2Null15
SUPPL3Null7
SUPPL7Null7
SUPPL9Null7
SUPPL12Null15
SUPPL13Null15

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB
004PrescriptionAB

CDER Filings

TORRENT
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203370
            [companyName] => TORRENT
            [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"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/23\/2013","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"11\/21\/2019","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert, Labeling-Medication Guide","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"11\/21\/2019","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"04\/25\/2017","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"04\/25\/2017","submission":"SUPPL-2","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-11-21
        )

)

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