GLAXOSMITHKLINE LLC FDA Approval NDA 022251

NDA 022251

GLAXOSMITHKLINE LLC

FDA Drug Application

Application #022251

Documents

Letter2010-11-03
Letter2015-03-25
Letter2015-01-07
Letter2011-08-08
Letter2012-08-02
Letter2015-03-25
Label2009-07-08
Label2015-01-05
Label2010-10-28
Label2015-03-25
Label2011-08-05
Label2011-12-02
Label2012-08-02
Label2015-05-21
Letter2009-05-13
Letter2013-12-26
Letter2015-01-07
Letter2010-11-03
Letter2011-06-02
Letter2011-12-02
Letter2014-06-12
Letter2015-05-20
Label2013-12-23
Label2010-10-28
Label2015-01-05
Label2015-03-25
Label2014-06-30
Review2010-05-27
Summary Review2010-05-27
Pediatric Medical Review1900-01-01
Pediatric Clinical Pharmacology Review1900-01-01
Pediatric Statistical Review1900-01-01
Label2018-07-05
Letter2018-07-06
Letter2018-07-24
Label2018-07-26
Medication Guide2018-07-26
Letter2019-08-15
Label2019-08-15
Letter2019-09-26
Label2019-09-26
Medication Guide2019-09-26
Letter2020-08-19
Letter2020-09-01
Label2020-09-04
Label2020-09-11
Medication Guide2020-09-11
Letter2020-10-14
Medication Guide2020-10-14
Label2020-10-14
Letter2021-04-01
Label2021-04-01
Medication Guide2021-04-01

Application Sponsors

NDA 022251GLAXOSMITHKLINE LLC

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004

Application Products

001TABLET, ORALLY DISINTEGRATING;ORAL25MG1LAMICTAL ODTLAMOTRIGINE
002TABLET, ORALLY DISINTEGRATING;ORAL50MG1LAMICTAL ODTLAMOTRIGINE
003TABLET, ORALLY DISINTEGRATING;ORAL100MG1LAMICTAL ODTLAMOTRIGINE
004TABLET, ORALLY DISINTEGRATING;ORAL200MG1LAMICTAL ODTLAMOTRIGINE

FDA Submissions

TYPE 3; Type 3 - New Dosage FormORIG1AP2009-05-08STANDARD
LABELING; LabelingSUPPL2AP2014-12-30UNKNOWN
REMS; REMSSUPPL5AP2010-10-24N/A
LABELING; LabelingSUPPL6AP2010-10-24UNKNOWN
LABELING; LabelingSUPPL7AP2015-03-24UNKNOWN
LABELING; LabelingSUPPL9AP2014-12-30UNKNOWN
LABELING; LabelingSUPPL10AP2011-08-04UNKNOWN
REMS; REMSSUPPL11AP2011-05-31N/A
LABELING; LabelingSUPPL12AP2011-11-29UNKNOWN
LABELING; LabelingSUPPL13AP2012-08-01UNKNOWN
LABELING; LabelingSUPPL14AP2015-03-24STANDARD
LABELING; LabelingSUPPL16AP2014-06-10STANDARD
EFFICACY; EfficacySUPPL17AP2015-05-18STANDARD
LABELING; LabelingSUPPL20AP2018-07-23STANDARD
LABELING; LabelingSUPPL21AP2018-06-27STANDARD
LABELING; LabelingSUPPL22AP2020-10-09STANDARD
LABELING; LabelingSUPPL23AP2019-08-14STANDARD
LABELING; LabelingSUPPL24AP2019-09-25STANDARD
LABELING; LabelingSUPPL25AP2020-08-19STANDARD
LABELING; LabelingSUPPL26AP2020-08-31STANDARD
LABELING; LabelingSUPPL28AP2021-03-31STANDARD

Submissions Property Types

ORIG1Null6
SUPPL2Null15
SUPPL5Null7
SUPPL6Null7
SUPPL7Null15
SUPPL9Null15
SUPPL10Null6
SUPPL11Null6
SUPPL12Null6
SUPPL13Null7
SUPPL14Null7
SUPPL16Null7
SUPPL17Null15
SUPPL20Null7
SUPPL21Null7
SUPPL22Null7
SUPPL23Null7
SUPPL24Null7
SUPPL25Null15
SUPPL26Null7
SUPPL28Null7

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB
004PrescriptionAB

CDER Filings

GLAXOSMITHKLINE LLC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 22251
            [companyName] => GLAXOSMITHKLINE LLC
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2019\/020241s060,020764s053,022251s024lbl.pdf#page=64"]
            [products] => [{"drugName":"LAMICTAL ODT","activeIngredients":"LAMOTRIGINE","strength":"25MG","dosageForm":"TABLET, ORALLY DISINTEGRATING;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"LAMICTAL ODT","activeIngredients":"LAMOTRIGINE","strength":"50MG","dosageForm":"TABLET, ORALLY DISINTEGRATING;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"LAMICTAL ODT","activeIngredients":"LAMOTRIGINE","strength":"100MG","dosageForm":"TABLET, ORALLY DISINTEGRATING;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"LAMICTAL ODT","activeIngredients":"LAMOTRIGINE","strength":"200MG","dosageForm":"TABLET, ORALLY DISINTEGRATING;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"09\/25\/2019","submission":"SUPPL-24","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/020241s060,020764s053,022251s024lbl.pdf\"}]","notes":""},{"actionDate":"08\/14\/2019","submission":"SUPPL-23","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/020241s059,020764s052,022251s023lbl.pdf\"}]","notes":""},{"actionDate":"07\/23\/2018","submission":"SUPPL-20","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/020241s056,020764s049,022251s020lbl.pdf\"}]","notes":""},{"actionDate":"06\/27\/2018","submission":"SUPPL-21","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/022251s021lbl.pdf\"}]","notes":""},{"actionDate":"05\/18\/2015","submission":"SUPPL-17","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/020241s053,020764s046,022251s017lbl.pdf\"}]","notes":""},{"actionDate":"03\/24\/2015","submission":"SUPPL-14","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/020241s045s051lbl.pdf\"}]","notes":""},{"actionDate":"03\/24\/2015","submission":"SUPPL-7","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/020241s045s051lbl.pdf\"}]","notes":""},{"actionDate":"12\/30\/2014","submission":"SUPPL-9","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/020241s035s040,020764s028s033,022251s002s009lbl.pdf\"}]","notes":""},{"actionDate":"12\/30\/2014","submission":"SUPPL-2","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/020241s035s040,020764s028s033,022251s002s009lbl.pdf\"}]","notes":""},{"actionDate":"06\/10\/2014","submission":"SUPPL-16","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/020241s052,020764s045,022251s016lbl.pdf\"}]","notes":""},{"actionDate":"12\/20\/2013","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/020241s039,020764s032,022251s001lbl.pdf\"}]","notes":""},{"actionDate":"08\/01\/2012","submission":"SUPPL-13","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/020241s050,020764s043,022251s013lbl.pdf\"}]","notes":""},{"actionDate":"11\/29\/2011","submission":"SUPPL-12","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/020241s049,020764s042,022251s012lbl.pdf\"}]","notes":""},{"actionDate":"08\/04\/2011","submission":"SUPPL-10","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/020241s047,020764s040,022251s010lbl.pdf\"}]","notes":""},{"actionDate":"10\/24\/2010","submission":"SUPPL-6","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/020241s043s044,020764s036s037,022251s005s006lbl.pdf\"}]","notes":""},{"actionDate":"10\/24\/2010","submission":"SUPPL-5","supplementCategories":"REMS-Proposal","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/020241s043s044,020764s036s037,022251s005s006lbl.pdf\"}]","notes":""},{"actionDate":"05\/08\/2009","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/022251,020764s029,020241s036lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"LAMICTAL ODT","submission":"LAMOTRIGINE","actionType":"25MG","submissionClassification":"TABLET, ORALLY DISINTEGRATING;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"LAMICTAL ODT","submission":"LAMOTRIGINE","actionType":"50MG","submissionClassification":"TABLET, ORALLY DISINTEGRATING;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"LAMICTAL ODT","submission":"LAMOTRIGINE","actionType":"100MG","submissionClassification":"TABLET, ORALLY DISINTEGRATING;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"LAMICTAL ODT","submission":"LAMOTRIGINE","actionType":"200MG","submissionClassification":"TABLET, ORALLY DISINTEGRATING;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2019-09-25
        )

)
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