Documents
Application Sponsors
| NDA 020764 | GLAXOSMITHKLINE LLC | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
| Discontinued | 003 |
| Prescription | 004 |
Application Products
| 001 | TABLET, CHEWABLE;ORAL | 5MG | 1 | LAMICTAL CD | LAMOTRIGINE |
| 002 | TABLET, CHEWABLE;ORAL | 25MG | 1 | LAMICTAL CD | LAMOTRIGINE |
| 003 | TABLET, CHEWABLE;ORAL | 100MG | 0 | LAMICTAL CD | LAMOTRIGINE |
| 004 | TABLET, CHEWABLE;ORAL | 2MG | 1 | LAMICTAL CD | LAMOTRIGINE |
FDA Submissions
| TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 1998-08-24 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 2 | AP | 2003-01-17 | STANDARD |
| LABELING; Labeling | SUPPL | 3 | AP | 2006-09-25 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1999-06-08 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 5 | AP | 2001-05-25 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 2000-09-08 | STANDARD |
| LABELING; Labeling | SUPPL | 8 | AP | 2001-02-23 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 9 | AP | 2004-01-14 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 11 | AP | 2003-06-20 | STANDARD |
| LABELING; Labeling | SUPPL | 14 | AP | 2006-09-25 | STANDARD |
| LABELING; Labeling | SUPPL | 18 | AP | 2006-09-25 | STANDARD |
| LABELING; Labeling | SUPPL | 19 | AP | 2006-09-25 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 20 | AP | 2006-09-22 | STANDARD |
| LABELING; Labeling | SUPPL | 22 | AP | 2006-03-17 | STANDARD |
| LABELING; Labeling | SUPPL | 28 | AP | 2014-12-30 | STANDARD |
| LABELING; Labeling | SUPPL | 29 | AP | 2009-05-08 | STANDARD |
| LABELING; Labeling | SUPPL | 30 | AP | 2009-04-23 | 901 REQUIRED |
| LABELING; Labeling | SUPPL | 31 | AP | 2009-04-23 | STANDARD |
| LABELING; Labeling | SUPPL | 32 | AP | 2013-12-20 | UNKNOWN |
| LABELING; Labeling | SUPPL | 33 | AP | 2014-12-30 | UNKNOWN |
| REMS; REMS | SUPPL | 36 | AP | 2010-10-24 | N/A |
| LABELING; Labeling | SUPPL | 37 | AP | 2010-10-24 | UNKNOWN |
| LABELING; Labeling | SUPPL | 38 | AP | 2015-03-24 | STANDARD |
| LABELING; Labeling | SUPPL | 40 | AP | 2011-08-04 | UNKNOWN |
| REMS; REMS | SUPPL | 41 | AP | 2011-05-31 | N/A |
| LABELING; Labeling | SUPPL | 42 | AP | 2011-11-29 | UNKNOWN |
| LABELING; Labeling | SUPPL | 43 | AP | 2012-08-01 | UNKNOWN |
| LABELING; Labeling | SUPPL | 44 | AP | 2015-03-24 | STANDARD |
| LABELING; Labeling | SUPPL | 45 | AP | 2014-06-10 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 46 | AP | 2015-05-18 | STANDARD |
| LABELING; Labeling | SUPPL | 49 | AP | 2018-07-23 | STANDARD |
| LABELING; Labeling | SUPPL | 50 | AP | 2018-06-27 | STANDARD |
| LABELING; Labeling | SUPPL | 51 | AP | 2020-10-09 | STANDARD |
| LABELING; Labeling | SUPPL | 52 | AP | 2019-08-14 | STANDARD |
| LABELING; Labeling | SUPPL | 53 | AP | 2019-09-25 | STANDARD |
| LABELING; Labeling | SUPPL | 54 | AP | 2020-08-19 | STANDARD |
| LABELING; Labeling | SUPPL | 55 | AP | 2020-08-31 | STANDARD |
| LABELING; Labeling | SUPPL | 57 | AP | 2021-03-31 | STANDARD |
Submissions Property Types
| SUPPL | 4 | Null | 0 |
| SUPPL | 6 | Null | 0 |
| SUPPL | 28 | Null | 7 |
| SUPPL | 31 | Null | 7 |
| SUPPL | 32 | Null | 6 |
| SUPPL | 33 | Null | 7 |
| SUPPL | 36 | Null | 6 |
| SUPPL | 37 | Null | 6 |
| SUPPL | 38 | Null | 6 |
| SUPPL | 40 | Null | 6 |
| SUPPL | 41 | Null | 6 |
| SUPPL | 42 | Null | 6 |
| SUPPL | 43 | Null | 7 |
| SUPPL | 44 | Null | 7 |
| SUPPL | 45 | Null | 15 |
| SUPPL | 46 | Null | 6 |
| SUPPL | 49 | Null | 7 |
| SUPPL | 50 | Null | 15 |
| SUPPL | 51 | Null | 6 |
| SUPPL | 52 | Null | 7 |
| SUPPL | 53 | Null | 15 |
| SUPPL | 54 | Null | 15 |
| SUPPL | 55 | Null | 7 |
| SUPPL | 57 | Null | 7 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
| 004 | Prescription | AB |
CDER Filings
GLAXOSMITHKLINE LLC
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(
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[companyName] => GLAXOSMITHKLINE LLC
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[originalApprovals] => [{"actionDate":"LAMICTAL CD","submission":"LAMOTRIGINE","actionType":"5MG","submissionClassification":"TABLET, CHEWABLE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"LAMICTAL CD","submission":"LAMOTRIGINE","actionType":"25MG","submissionClassification":"TABLET, CHEWABLE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"LAMICTAL CD","submission":"LAMOTRIGINE","actionType":"100MG","submissionClassification":"TABLET, CHEWABLE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"LAMICTAL CD","submission":"LAMOTRIGINE","actionType":"2MG","submissionClassification":"TABLET, CHEWABLE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2020-08-31
)
)