Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022115
Company: GLAXOSMITHKLINE LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LAMICTAL XR LAMOTRIGINE 25MG TABLET, EXTENDED RELEASE;ORAL Prescription AB Yes No
LAMICTAL XR LAMOTRIGINE 50MG TABLET, EXTENDED RELEASE;ORAL Prescription AB Yes Yes
LAMICTAL XR LAMOTRIGINE 100MG TABLET, EXTENDED RELEASE;ORAL Prescription AB Yes No
LAMICTAL XR LAMOTRIGINE 200MG TABLET, EXTENDED RELEASE;ORAL Prescription AB Yes Yes
LAMICTAL XR LAMOTRIGINE 300MG TABLET, EXTENDED RELEASE;ORAL Prescription AB Yes No
LAMICTAL XR LAMOTRIGINE 250MG TABLET, EXTENDED RELEASE;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
05/29/2009 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/2009/022115lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022115s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022115s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022115s000_SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/14/2019 SUPPL-25 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022115s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020241Orig1s059, 020764Orig1s052, 022251Orig1s023, 022115Orig1s025ltr.pdf
06/27/2018 SUPPL-23 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022115s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/020241Orig1s057,020764Orig1s050,022115Orig1s023,022251Orig1s021ltr.pdf
07/23/2018 SUPPL-22 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022115s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020241Orig1s056,020764Orig1s049,022115Orig1s022,022251Orig1s020ltr.pdf
06/10/2014 SUPPL-19 Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022115s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020241Orig1s052,020764Orig1s045,022251Orig1s016,022115Orig1s019ltr.pdf
03/24/2015 SUPPL-18 Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022115s011s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020241Orig1s045,051,020764Orig1s038,044,022251Orig1s007,014,022115Orig1s011,018ltr.pdf
08/01/2012 SUPPL-17 Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022115s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020241Orig1s050,020764Orig1s043,022251Orig1s013,022115Orig1s017ltr.pdf
11/29/2011 SUPPL-16 Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022115s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020241s049,020764s042,022251s012,022115s016ltr.pdf
06/21/2011 SUPPL-15 REMS-Modified Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022115s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022115s015ltr.pdf
12/30/2014 SUPPL-14 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022115s004s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020241s035s040,020764s028s033,022115s004s014,022251s002s009ltr.pdf
08/04/2011 SUPPL-13 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022115s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022115s013,020241s047,020764s040,022251s010ltr.pdf
03/24/2015 SUPPL-11 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022115s011s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020241Orig1s045,051,020764Orig1s038,044,022251Orig1s007,014,022115Orig1s011,018ltr.pdf
10/24/2010 SUPPL-10 Labeling-Medication Guide Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022115s009s010lbl.pdf
10/24/2010 SUPPL-9 REMS-Proposal Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022115s009s010lbl.pdf
04/25/2011 SUPPL-6 Efficacy-New Patient Population, REMS-Modified Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022115s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022115s006ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/022115Orig1s006.pdf
04/14/2010 SUPPL-5 REMS-Proposal, REMS-Assessment Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022115s001s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022115s001,s005ltr.pdf
12/30/2014 SUPPL-4 Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022115s004s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020241s035s040,020764s028s033,022115s004s014,022251s002s009ltr.pdf
12/20/2013 SUPPL-3 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022115 s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020241Orig1s039;020764Orig1s032;022251Orig1s001;022115Orig1s003ltr.pdf
04/14/2010 SUPPL-1 Manufacturing (CMC) Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022115s001s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022115s001,s005ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/14/2019 SUPPL-25 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022115s025lbl.pdf
07/23/2018 SUPPL-22 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022115s022lbl.pdf
06/27/2018 SUPPL-23 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022115s023lbl.pdf
03/24/2015 SUPPL-18 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022115s011s018lbl.pdf
03/24/2015 SUPPL-11 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022115s011s018lbl.pdf
12/30/2014 SUPPL-14 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022115s004s014lbl.pdf
12/30/2014 SUPPL-4 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022115s004s014lbl.pdf
06/10/2014 SUPPL-19 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022115s019lbl.pdf
12/20/2013 SUPPL-3 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022115 s003lbl.pdf
08/01/2012 SUPPL-17 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022115s017lbl.pdf
11/29/2011 SUPPL-16 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022115s016lbl.pdf
08/04/2011 SUPPL-13 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022115s013lbl.pdf
06/21/2011 SUPPL-15 REMS-Modified Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022115s015lbl.pdf
04/25/2011 SUPPL-6 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022115s006lbl.pdf
04/25/2011 SUPPL-6 REMS-Modified Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022115s006lbl.pdf
10/24/2010 SUPPL-10 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022115s009s010lbl.pdf
10/24/2010 SUPPL-9 REMS-Proposal Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022115s009s010lbl.pdf
04/14/2010 SUPPL-5 REMS-Proposal Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022115s001s005lbl.pdf
04/14/2010 SUPPL-5 REMS-Assessment Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022115s001s005lbl.pdf
04/14/2010 SUPPL-1 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022115s001s005lbl.pdf
05/29/2009 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022115lbl.pdf

LAMICTAL XR

TABLET, EXTENDED RELEASE;ORAL; 25MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LAMICTAL XR LAMOTRIGINE 25MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 022115 GLAXOSMITHKLINE LLC
LAMOTRIGINE LAMOTRIGINE 25MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 200672 ACTAVIS ELIZABETH
LAMOTRIGINE LAMOTRIGINE 25MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 207497 AMNEAL PHARMS
LAMOTRIGINE LAMOTRIGINE 25MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 201374 ANCHEN PHARMS
LAMOTRIGINE LAMOTRIGINE 25MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 202383 DR REDDYS LABS LTD
LAMOTRIGINE LAMOTRIGINE 25MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 201791 PAR PHARM
LAMOTRIGINE LAMOTRIGINE 25MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 203370 TORRENT
LAMOTRIGINE LAMOTRIGINE 25MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 202498 WOCKHARDT LTD

TABLET, EXTENDED RELEASE;ORAL; 50MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LAMICTAL XR LAMOTRIGINE 50MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 022115 GLAXOSMITHKLINE LLC
LAMOTRIGINE LAMOTRIGINE 50MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 200672 ACTAVIS ELIZABETH
LAMOTRIGINE LAMOTRIGINE 50MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 207497 AMNEAL PHARMS
LAMOTRIGINE LAMOTRIGINE 50MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 201374 ANCHEN PHARMS
LAMOTRIGINE LAMOTRIGINE 50MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 202383 DR REDDYS LABS LTD
LAMOTRIGINE LAMOTRIGINE 50MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 201791 PAR PHARM
LAMOTRIGINE LAMOTRIGINE 50MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 203370 TORRENT
LAMOTRIGINE LAMOTRIGINE 50MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 202498 WOCKHARDT LTD

TABLET, EXTENDED RELEASE;ORAL; 100MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LAMICTAL XR LAMOTRIGINE 100MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 022115 GLAXOSMITHKLINE LLC
LAMOTRIGINE LAMOTRIGINE 100MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 200672 ACTAVIS ELIZABETH
LAMOTRIGINE LAMOTRIGINE 100MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 207497 AMNEAL PHARMS
LAMOTRIGINE LAMOTRIGINE 100MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 201374 ANCHEN PHARMS
LAMOTRIGINE LAMOTRIGINE 100MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 202383 DR REDDYS LABS LTD
LAMOTRIGINE LAMOTRIGINE 100MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 201791 PAR PHARM
LAMOTRIGINE LAMOTRIGINE 100MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 202887 RUBICON
LAMOTRIGINE LAMOTRIGINE 100MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 203370 TORRENT
LAMOTRIGINE LAMOTRIGINE 100MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 202498 WOCKHARDT LTD

TABLET, EXTENDED RELEASE;ORAL; 200MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LAMICTAL XR LAMOTRIGINE 200MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 022115 GLAXOSMITHKLINE LLC
LAMOTRIGINE LAMOTRIGINE 200MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 200672 ACTAVIS ELIZABETH
LAMOTRIGINE LAMOTRIGINE 200MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 207497 AMNEAL PHARMS
LAMOTRIGINE LAMOTRIGINE 200MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 201374 ANCHEN PHARMS
LAMOTRIGINE LAMOTRIGINE 200MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 202383 DR REDDYS LABS LTD
LAMOTRIGINE LAMOTRIGINE 200MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 201791 PAR PHARM
LAMOTRIGINE LAMOTRIGINE 200MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 202887 RUBICON
LAMOTRIGINE LAMOTRIGINE 200MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 203370 TORRENT
LAMOTRIGINE LAMOTRIGINE 200MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 202498 WOCKHARDT LTD

TABLET, EXTENDED RELEASE;ORAL; 300MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LAMICTAL XR LAMOTRIGINE 300MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 022115 GLAXOSMITHKLINE LLC
LAMOTRIGINE LAMOTRIGINE 300MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 200672 ACTAVIS ELIZABETH
LAMOTRIGINE LAMOTRIGINE 300MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 207497 AMNEAL PHARMS
LAMOTRIGINE LAMOTRIGINE 300MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 201374 ANCHEN PHARMS
LAMOTRIGINE LAMOTRIGINE 300MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 202383 DR REDDYS LABS LTD
LAMOTRIGINE LAMOTRIGINE 300MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 201791 PAR PHARM
LAMOTRIGINE LAMOTRIGINE 300MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 202498 WOCKHARDT LTD

TABLET, EXTENDED RELEASE;ORAL; 250MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LAMICTAL XR LAMOTRIGINE 250MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 022115 GLAXOSMITHKLINE LLC
LAMOTRIGINE LAMOTRIGINE 250MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 203733 ACTAVIS ELIZABETH
LAMOTRIGINE LAMOTRIGINE 250MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 207497 AMNEAL PHARMS
LAMOTRIGINE LAMOTRIGINE 250MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 201374 ANCHEN PHARMS
LAMOTRIGINE LAMOTRIGINE 250MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 201791 PAR PHARM

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