Documents
Application Sponsors
| NDA 020241 | GLAXOSMITHKLINE LLC | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
| Prescription | 003 |
| Discontinued | 004 |
| Prescription | 005 |
| Discontinued | 006 |
Application Products
| 001 | TABLET;ORAL | 100MG | 1 | LAMICTAL | LAMOTRIGINE |
| 002 | TABLET;ORAL | 150MG | 1 | LAMICTAL | LAMOTRIGINE |
| 003 | TABLET;ORAL | 200MG | 1 | LAMICTAL | LAMOTRIGINE |
| 004 | TABLET;ORAL | 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | LAMICTAL | LAMOTRIGINE |
| 005 | TABLET;ORAL | 25MG | 1 | LAMICTAL | LAMOTRIGINE |
| 006 | TABLET;ORAL | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | LAMICTAL | LAMOTRIGINE |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 1994-12-27 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 2 | AP | 1998-08-24 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 3 | AP | 1998-12-14 | STANDARD |
| LABELING; Labeling | SUPPL | 4 | AP | 1997-03-11 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1998-03-16 | PRIORITY |
| LABELING; Labeling | SUPPL | 6 | AP | 1998-03-16 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1999-05-10 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 8 | AP | 2003-01-17 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1999-06-08 | PRIORITY |
| LABELING; Labeling | SUPPL | 10 | AP | 2006-09-25 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 11 | AP | 2001-05-25 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 2000-06-12 | PRIORITY |
| LABELING; Labeling | SUPPL | 14 | AP | 2000-09-08 | STANDARD |
| LABELING; Labeling | SUPPL | 15 | AP | 2001-02-23 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 16 | AP | 2004-01-14 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 17 | AP | 2003-06-20 | STANDARD |
| LABELING; Labeling | SUPPL | 18 | AP | 2003-04-04 | STANDARD |
| LABELING; Labeling | SUPPL | 21 | AP | 2006-09-25 | STANDARD |
| LABELING; Labeling | SUPPL | 25 | AP | 2006-09-25 | STANDARD |
| LABELING; Labeling | SUPPL | 26 | AP | 2006-09-25 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 27 | AP | 2006-09-22 | STANDARD |
| LABELING; Labeling | SUPPL | 29 | AP | 2006-03-17 | STANDARD |
| LABELING; Labeling | SUPPL | 35 | AP | 2014-12-30 | STANDARD |
| LABELING; Labeling | SUPPL | 36 | AP | 2009-05-08 | STANDARD |
| LABELING; Labeling | SUPPL | 37 | AP | 2009-04-23 | 901 REQUIRED |
| LABELING; Labeling | SUPPL | 38 | AP | 2009-04-23 | STANDARD |
| LABELING; Labeling | SUPPL | 39 | AP | 2013-12-20 | UNKNOWN |
| LABELING; Labeling | SUPPL | 40 | AP | 2014-12-30 | UNKNOWN |
| REMS; REMS | SUPPL | 43 | AP | 2010-10-24 | N/A |
| LABELING; Labeling | SUPPL | 44 | AP | 2010-10-24 | UNKNOWN |
| LABELING; Labeling | SUPPL | 45 | AP | 2015-03-24 | STANDARD |
| LABELING; Labeling | SUPPL | 47 | AP | 2011-08-04 | UNKNOWN |
| REMS; REMS | SUPPL | 48 | AP | 2011-05-31 | N/A |
| LABELING; Labeling | SUPPL | 49 | AP | 2011-11-29 | UNKNOWN |
| LABELING; Labeling | SUPPL | 50 | AP | 2012-08-01 | UNKNOWN |
| LABELING; Labeling | SUPPL | 51 | AP | 2015-03-24 | STANDARD |
| LABELING; Labeling | SUPPL | 52 | AP | 2014-06-10 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 53 | AP | 2015-05-18 | STANDARD |
| LABELING; Labeling | SUPPL | 56 | AP | 2018-07-23 | STANDARD |
| LABELING; Labeling | SUPPL | 57 | AP | 2018-06-27 | STANDARD |
| LABELING; Labeling | SUPPL | 58 | AP | 2020-10-09 | STANDARD |
| LABELING; Labeling | SUPPL | 59 | AP | 2019-08-14 | STANDARD |
| LABELING; Labeling | SUPPL | 60 | AP | 2019-09-25 | STANDARD |
| LABELING; Labeling | SUPPL | 61 | AP | 2020-08-19 | STANDARD |
| LABELING; Labeling | SUPPL | 62 | AP | 2020-08-31 | STANDARD |
| LABELING; Labeling | SUPPL | 64 | AP | 2021-03-31 | STANDARD |
Submissions Property Types
| SUPPL | 5 | Null | 0 |
| SUPPL | 7 | Null | 0 |
| SUPPL | 9 | Null | 0 |
| SUPPL | 12 | Null | 0 |
| SUPPL | 35 | Null | 6 |
| SUPPL | 38 | Null | 7 |
| SUPPL | 39 | Null | 6 |
| SUPPL | 40 | Null | 6 |
| SUPPL | 43 | Null | 6 |
| SUPPL | 44 | Null | 6 |
| SUPPL | 45 | Null | 6 |
| SUPPL | 47 | Null | 6 |
| SUPPL | 48 | Null | 6 |
| SUPPL | 49 | Null | 6 |
| SUPPL | 50 | Null | 6 |
| SUPPL | 51 | Null | 7 |
| SUPPL | 52 | Null | 7 |
| SUPPL | 53 | Null | 15 |
| SUPPL | 56 | Null | 7 |
| SUPPL | 57 | Null | 7 |
| SUPPL | 58 | Null | 15 |
| SUPPL | 59 | Null | 7 |
| SUPPL | 60 | Null | 7 |
| SUPPL | 61 | Null | 15 |
| SUPPL | 62 | Null | 7 |
| SUPPL | 64 | Null | 7 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
| 003 | Prescription | AB |
| 005 | Prescription | AB |
CDER Filings
GLAXOSMITHKLINE LLC
cder:Array
(
[0] => Array
(
[ApplNo] => 20241
[companyName] => GLAXOSMITHKLINE LLC
[docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2019\/020241s060,020764s053,022251s024lbl.pdf#page=64"]
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(PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/020241s045s051lbl.pdf\"}]","notes":""},{"actionDate":"12\/30\/2014","submission":"SUPPL-40","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":"12\/30\/2014","submission":"SUPPL-35","supplementCategories":"Labeling","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-52","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label 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[originalApprovals] => [{"actionDate":"LAMICTAL","submission":"LAMOTRIGINE","actionType":"100MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"LAMICTAL","submission":"LAMOTRIGINE","actionType":"150MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"LAMICTAL","submission":"LAMOTRIGINE","actionType":"200MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"LAMICTAL","submission":"LAMOTRIGINE","actionType":"250MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"LAMICTAL","submission":"LAMOTRIGINE","actionType":"25MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"LAMICTAL","submission":"LAMOTRIGINE","actionType":"50MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2019-09-25
)
)