Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022251
Company: GLAXOSMITHKLINE LLC
Company: GLAXOSMITHKLINE LLC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LAMICTAL ODT | LAMOTRIGINE | 25MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | AB | Yes | No |
| LAMICTAL ODT | LAMOTRIGINE | 50MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | AB | Yes | Yes |
| LAMICTAL ODT | LAMOTRIGINE | 100MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | AB | Yes | No |
| LAMICTAL ODT | LAMOTRIGINE | 200MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | AB | Yes | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 05/08/2009 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022251,020764s029,020241s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022251s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022251_lamictal_odt_lamotrigine.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022251s000_SumR.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/31/2021 | SUPPL-28 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020241s064,020764s057,022251s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020241Orig1s064, 020764Orig1s057, 022251Orig1s028, 022115Orig1s029ltr.pdf | |
| 08/31/2020 | SUPPL-26 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020241s062,020764s055,022251s026,022115s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020241Orig1s062, 020764Orig1s055, 022251Orig1s026, 022115Orig1s027ltr.pdf | |
| 08/19/2020 | SUPPL-25 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020241Orig1s061ltr,020764Orig1s054,022251Orig1s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020241Orig1s061ltrini,020764Orig1s054,022251Orig1s025ltr.pdf | |
| 09/25/2019 | SUPPL-24 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020241s060,020764s053,022251s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020241Orig1s060, 020764Orig1s053, 022251Orig1s024, 022115Orig1s026ltr.pdf | |
| 08/14/2019 | SUPPL-23 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020241s059,020764s052,022251s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020241Orig1s059, 020764Orig1s052, 022251Orig1s023, 022115Orig1s025ltr.pdf | |
| 10/09/2020 | SUPPL-22 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020241s058,020764s051,022251s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020241Orig1s058, 020764Orig1s051, 022251Orig1s022, 022115Orig1s024ltr.pdf | |
| 06/27/2018 | SUPPL-21 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022251s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020241Orig1s057,020764Orig1s050,022115Orig1s023,022251Orig1s021ltr.pdf | |
| 07/23/2018 | SUPPL-20 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020241s056,020764s049,022251s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020241Orig1s056,020764Orig1s049,022115Orig1s022,022251Orig1s020ltr.pdf | |
| 05/18/2015 | SUPPL-17 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020241s053,020764s046,022251s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022251Orig1s017,020241Orig1s053,020764Orig1s046ltr.pdf | |
| 06/10/2014 | SUPPL-16 | Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020241s052,020764s045,022251s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020241Orig1s052,020764Orig1s045,022251Orig1s016,022115Orig1s019ltr.pdf | |
| 03/24/2015 | SUPPL-14 | Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020241s045s051lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020241Orig1s045,051,020764Orig1s038,044,022251Orig1s007,014,022115Orig1s011,018ltr.pdf | |
| 08/01/2012 | SUPPL-13 | Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020241s050,020764s043,022251s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020241Orig1s050,020764Orig1s043,022251Orig1s013,022115Orig1s017ltr.pdf | |
| 11/29/2011 | SUPPL-12 | Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020241s049,020764s042,022251s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020241s049,020764s042,022251s012,022115s016ltr.pdf | |
| 05/31/2011 | SUPPL-11 | REMS-Modified |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020241s048,020764s041,022251s011ltr.pdf |
| 08/04/2011 | SUPPL-10 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020241s047,020764s040,022251s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022115s013,020241s047,020764s040,022251s010ltr.pdf | |
| 12/30/2014 | SUPPL-9 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020241s035s040,020764s028s033,022251s002s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020241s035s040,020764s028s033,022115s004s014,022251s002s009ltr.pdf | |
| 03/24/2015 | SUPPL-7 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020241s045s051lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020241Orig1s045,051,020764Orig1s038,044,022251Orig1s007,014,022115Orig1s011,018ltr.pdf | |
| 10/24/2010 | SUPPL-6 | Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020241s043s044,020764s036s037,022251s005s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020241s043,s044,020764s036,s037,022251s005,s006ltr.pdf | |
| 10/24/2010 | SUPPL-5 | REMS-Proposal |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020241s043s044,020764s036s037,022251s005s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020241s043,s044,020764s036,s037,022251s005,s006ltr.pdf | |
| 12/30/2014 | SUPPL-2 | Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020241s035s040,020764s028s033,022251s002s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020241s035s040,020764s028s033,022115s004s014,022251s002s009ltr.pdf | |
| 12/20/2013 | SUPPL-1 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020241s039,020764s032,022251s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020241Orig1s039;020764Orig1s032;022251Orig1s001;022115Orig1s003ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 03/31/2021 | SUPPL-28 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020241s064,020764s057,022251s028lbl.pdf | |
| 10/09/2020 | SUPPL-22 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020241s058,020764s051,022251s022lbl.pdf | |
| 08/31/2020 | SUPPL-26 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020241s062,020764s055,022251s026,022115s027lbl.pdf | |
| 08/19/2020 | SUPPL-25 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020241Orig1s061ltr,020764Orig1s054,022251Orig1s025lbl.pdf | |
| 08/19/2020 | SUPPL-25 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020241Orig1s061ltr,020764Orig1s054,022251Orig1s025lbl.pdf | |
| 09/25/2019 | SUPPL-24 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020241s060,020764s053,022251s024lbl.pdf | |
| 08/14/2019 | SUPPL-23 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020241s059,020764s052,022251s023lbl.pdf | |
| 07/23/2018 | SUPPL-20 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020241s056,020764s049,022251s020lbl.pdf | |
| 06/27/2018 | SUPPL-21 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022251s021lbl.pdf | |
| 05/18/2015 | SUPPL-17 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020241s053,020764s046,022251s017lbl.pdf | |
| 03/24/2015 | SUPPL-14 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020241s045s051lbl.pdf | |
| 03/24/2015 | SUPPL-7 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020241s045s051lbl.pdf | |
| 12/30/2014 | SUPPL-9 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020241s035s040,020764s028s033,022251s002s009lbl.pdf | |
| 12/30/2014 | SUPPL-2 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020241s035s040,020764s028s033,022251s002s009lbl.pdf | |
| 06/10/2014 | SUPPL-16 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020241s052,020764s045,022251s016lbl.pdf | |
| 12/20/2013 | SUPPL-1 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020241s039,020764s032,022251s001lbl.pdf | |
| 08/01/2012 | SUPPL-13 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020241s050,020764s043,022251s013lbl.pdf | |
| 11/29/2011 | SUPPL-12 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020241s049,020764s042,022251s012lbl.pdf | |
| 08/04/2011 | SUPPL-10 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020241s047,020764s040,022251s010lbl.pdf | |
| 10/24/2010 | SUPPL-6 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020241s043s044,020764s036s037,022251s005s006lbl.pdf | |
| 10/24/2010 | SUPPL-5 | REMS-Proposal | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020241s043s044,020764s036s037,022251s005s006lbl.pdf | |
| 05/08/2009 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022251,020764s029,020241s036lbl.pdf |
LAMICTAL ODT
TABLET, ORALLY DISINTEGRATING;ORAL; 25MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| LAMICTAL ODT | LAMOTRIGINE | 25MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | Yes | AB | 022251 | GLAXOSMITHKLINE LLC |
| LAMOTRIGINE | LAMOTRIGINE | 25MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 213271 | AJANTA PHARMA LTD |
| LAMOTRIGINE | LAMOTRIGINE | 25MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 214124 | AMRING PHARMS |
| LAMOTRIGINE | LAMOTRIGINE | 25MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 204158 | PAR PHARM |
| LAMOTRIGINE | LAMOTRIGINE | 25MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 206382 | SCIEGEN PHARMS INC |
TABLET, ORALLY DISINTEGRATING;ORAL; 50MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| LAMICTAL ODT | LAMOTRIGINE | 50MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | Yes | AB | 022251 | GLAXOSMITHKLINE LLC |
| LAMOTRIGINE | LAMOTRIGINE | 50MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 213271 | AJANTA PHARMA LTD |
| LAMOTRIGINE | LAMOTRIGINE | 50MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 214124 | AMRING PHARMS |
| LAMOTRIGINE | LAMOTRIGINE | 50MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 204158 | PAR PHARM |
| LAMOTRIGINE | LAMOTRIGINE | 50MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 206382 | SCIEGEN PHARMS INC |
TABLET, ORALLY DISINTEGRATING;ORAL; 100MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| LAMICTAL ODT | LAMOTRIGINE | 100MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | Yes | AB | 022251 | GLAXOSMITHKLINE LLC |
| LAMOTRIGINE | LAMOTRIGINE | 100MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 213271 | AJANTA PHARMA LTD |
| LAMOTRIGINE | LAMOTRIGINE | 100MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 214124 | AMRING PHARMS |
| LAMOTRIGINE | LAMOTRIGINE | 100MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 204158 | PAR PHARM |
| LAMOTRIGINE | LAMOTRIGINE | 100MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 206382 | SCIEGEN PHARMS INC |
TABLET, ORALLY DISINTEGRATING;ORAL; 200MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| LAMICTAL ODT | LAMOTRIGINE | 200MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | Yes | AB | 022251 | GLAXOSMITHKLINE LLC |
| LAMOTRIGINE | LAMOTRIGINE | 200MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 213271 | AJANTA PHARMA LTD |
| LAMOTRIGINE | LAMOTRIGINE | 200MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 214124 | AMRING PHARMS |
| LAMOTRIGINE | LAMOTRIGINE | 200MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 204158 | PAR PHARM |
| LAMOTRIGINE | LAMOTRIGINE | 200MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 206382 | SCIEGEN PHARMS INC |