Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020764
Company: GLAXOSMITHKLINE LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LAMICTAL CD LAMOTRIGINE 5MG TABLET, CHEWABLE;ORAL Prescription AB Yes No
LAMICTAL CD LAMOTRIGINE 25MG TABLET, CHEWABLE;ORAL Prescription AB Yes Yes
LAMICTAL CD LAMOTRIGINE 100MG TABLET, CHEWABLE;ORAL Discontinued None No No
LAMICTAL CD LAMOTRIGINE 2MG TABLET, CHEWABLE;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
08/24/1998 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20764lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20764ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020764a.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/27/2018 SUPPL-50 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020764s050lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020241Orig1s057,020764Orig1s050,022115Orig1s023,022251Orig1s021ltr.pdf
07/23/2018 SUPPL-49 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-46 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-45 Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020241Orig1s052,020764Orig1s045,022251Orig1s016Lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020241Orig1s052,020764Orig1s045,022251Orig1s016,022115Orig1s019ltr.pdf
03/24/2015 SUPPL-44 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-43 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-42 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-41 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-40 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
03/24/2015 SUPPL-38 Labeling-Package Insert 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-37 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-36 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-33 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-32 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
04/23/2009 SUPPL-31 REMS-Proposal, Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020241s037s038,020764s030s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020241s037,s038,020764s030,s031ltr.pdf
04/23/2009 SUPPL-30 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020241s037s038,020764s030s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020241s037,s038,020764s030,s031ltr.pdf
05/08/2009 SUPPL-29 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022251,020764s029,020241s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020764s029ltr.pdf
12/30/2014 SUPPL-28 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
03/17/2006 SUPPL-22 Labeling

Label is not available on this site.

09/22/2006 SUPPL-20 Efficacy-New Indication Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020241SLRs10s21s25s26s27,020764SLRs3s14s18s19s20lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020241s10,s21,s25,s27,020764s3,s14,s18,s19,s20LTR.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/020764_s020_Lamictal-optimized.pdf
09/25/2006 SUPPL-19 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020241SLRs10s21s25s26s27,020764SLRs3s14s18s19s20lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020241s10,s21,s25,s27,020764s3,s14,s18,s19,s20LTR.pdf
09/25/2006 SUPPL-18 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020241SLRs10s21s25s26s27,020764SLRs3s14s18s19s20lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020241s10,s21,s25,s27,020764s3,s14,s18,s19,s20LTR.pdf
09/25/2006 SUPPL-14 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020241SLRs10s21s25s26s27,020764SLRs3s14s18s19s20lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020241s10,s21,s25,s27,020764s3,s14,s18,s19,s20LTR.pdf
06/20/2003 SUPPL-11 Efficacy-New Indication Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20241se1-017,20764se1-011_lamictal_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20241se1-017,20764se1-011ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020241_S017_020764_S011TOC.cfm
01/14/2004 SUPPL-9 Efficacy-Labeling Change With Clinical Data Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20241se8-016,20764se8-009ltr.pdf
02/23/2001 SUPPL-8 Labeling

Label is not available on this site.

09/08/2000 SUPPL-6 Manufacturing (CMC)-Formulation

Label is not available on this site.

05/25/2001 SUPPL-5 Efficacy-Labeling Change With Clinical Data Label (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20764s5lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020764_S005.pdf
06/08/1999 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

09/25/2006 SUPPL-3 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020241SLRs10s21s25s26s27,020764SLRs3s14s18s19s20lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020241s10,s21,s25,s27,020764s3,s14,s18,s19,s20LTR.pdf
01/17/2003 SUPPL-2 Efficacy-New Indication Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020241s008lbl.pdf
12/14/1998 SUPPL-1 Efficacy-New Indication Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20241s03lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20241s3ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020241s003.cfm
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/23/2018 SUPPL-49 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020241s056,020764s049,022251s020lbl.pdf
06/27/2018 SUPPL-50 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020764s050lbl.pdf
05/18/2015 SUPPL-46 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020241s053,020764s046,022251s017lbl.pdf
03/24/2015 SUPPL-44 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020241s045s051lbl.pdf
03/24/2015 SUPPL-38 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020241s045s051lbl.pdf
12/30/2014 SUPPL-33 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020241s035s040,020764s028s033,022251s002s009lbl.pdf
12/30/2014 SUPPL-28 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020241s035s040,020764s028s033,022251s002s009lbl.pdf
06/10/2014 SUPPL-45 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020241Orig1s052,020764Orig1s045,022251Orig1s016Lbl.pdf
12/20/2013 SUPPL-32 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020241s039,020764s032,022251s001lbl.pdf
08/01/2012 SUPPL-43 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020241s050,020764s043,022251s013lbl.pdf
11/29/2011 SUPPL-42 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020241s049,020764s042,022251s012lbl.pdf
08/04/2011 SUPPL-40 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020241s047,020764s040,022251s010lbl.pdf
10/24/2010 SUPPL-37 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020241s043s044,020764s036s037,022251s005s006lbl.pdf
10/24/2010 SUPPL-36 REMS-Proposal Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020241s043s044,020764s036s037,022251s005s006lbl.pdf
05/08/2009 SUPPL-29 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022251,020764s029,020241s036lbl.pdf
04/23/2009 SUPPL-31 REMS-Proposal Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020241s037s038,020764s030s031lbl.pdf
04/23/2009 SUPPL-31 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020241s037s038,020764s030s031lbl.pdf
04/23/2009 SUPPL-30 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020241s037s038,020764s030s031lbl.pdf
09/25/2006 SUPPL-19 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020241SLRs10s21s25s26s27,020764SLRs3s14s18s19s20lbl.pdf
09/25/2006 SUPPL-18 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020241SLRs10s21s25s26s27,020764SLRs3s14s18s19s20lbl.pdf
09/25/2006 SUPPL-14 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020241SLRs10s21s25s26s27,020764SLRs3s14s18s19s20lbl.pdf
09/25/2006 SUPPL-3 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020241SLRs10s21s25s26s27,020764SLRs3s14s18s19s20lbl.pdf
09/22/2006 SUPPL-20 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020241SLRs10s21s25s26s27,020764SLRs3s14s18s19s20lbl.pdf
06/20/2003 SUPPL-11 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20241se1-017,20764se1-011_lamictal_lbl.pdf
01/17/2003 SUPPL-2 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020241s008lbl.pdf
05/25/2001 SUPPL-5 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20764s5lbl.pdf
12/14/1998 SUPPL-1 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20241s03lbl.pdf
08/24/1998 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20764lbl.pdf

LAMICTAL CD

TABLET, CHEWABLE;ORAL; 5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LAMICTAL CD LAMOTRIGINE 5MG TABLET, CHEWABLE;ORAL Prescription Yes AB 020764 GLAXOSMITHKLINE LLC
LAMOTRIGINE LAMOTRIGINE 5MG TABLET, CHEWABLE;ORAL Prescription No AB 201168 ALEMBIC PHARMS LTD
LAMOTRIGINE LAMOTRIGINE 5MG TABLET, CHEWABLE;ORAL Prescription No AB 090401 AUROBINDO PHARMA
LAMOTRIGINE LAMOTRIGINE 5MG TABLET, CHEWABLE;ORAL Prescription No AB 076701 DR REDDYS LABS LTD
LAMOTRIGINE LAMOTRIGINE 5MG TABLET, CHEWABLE;ORAL Prescription No AB 079099 GLENMARK PHARMS LTD
LAMOTRIGINE LAMOTRIGINE 5MG TABLET, CHEWABLE;ORAL Prescription No AB 200220 JUBILANT GENERICS
LAMOTRIGINE LAMOTRIGINE 5MG TABLET, CHEWABLE;ORAL Prescription No AB 079204 TARO
LAMOTRIGINE LAMOTRIGINE 5MG TABLET, CHEWABLE;ORAL Prescription No AB 076420 TEVA
LAMOTRIGINE LAMOTRIGINE 5MG TABLET, CHEWABLE;ORAL Prescription No AB 076928 WATSON LABS
LAMOTRIGINE LAMOTRIGINE 5MG TABLET, CHEWABLE;ORAL Prescription No AB 078009 ZYDUS PHARMS USA INC

TABLET, CHEWABLE;ORAL; 25MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LAMICTAL CD LAMOTRIGINE 25MG TABLET, CHEWABLE;ORAL Prescription Yes AB 020764 GLAXOSMITHKLINE LLC
LAMOTRIGINE LAMOTRIGINE 25MG TABLET, CHEWABLE;ORAL Prescription No AB 201168 ALEMBIC PHARMS LTD
LAMOTRIGINE LAMOTRIGINE 25MG TABLET, CHEWABLE;ORAL Prescription No AB 090401 AUROBINDO PHARMA
LAMOTRIGINE LAMOTRIGINE 25MG TABLET, CHEWABLE;ORAL Prescription No AB 076701 DR REDDYS LABS LTD
LAMOTRIGINE LAMOTRIGINE 25MG TABLET, CHEWABLE;ORAL Prescription No AB 079099 GLENMARK PHARMS LTD
LAMOTRIGINE LAMOTRIGINE 25MG TABLET, CHEWABLE;ORAL Prescription No AB 200220 JUBILANT GENERICS
LAMOTRIGINE LAMOTRIGINE 25MG TABLET, CHEWABLE;ORAL Prescription No AB 079204 TARO
LAMOTRIGINE LAMOTRIGINE 25MG TABLET, CHEWABLE;ORAL Prescription No AB 076420 TEVA
LAMOTRIGINE LAMOTRIGINE 25MG TABLET, CHEWABLE;ORAL Prescription No AB 076928 WATSON LABS
LAMOTRIGINE LAMOTRIGINE 25MG TABLET, CHEWABLE;ORAL Prescription No AB 078009 ZYDUS PHARMS USA INC

TABLET, CHEWABLE;ORAL; 2MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LAMICTAL CD LAMOTRIGINE 2MG TABLET, CHEWABLE;ORAL Prescription Yes AB 020764 GLAXOSMITHKLINE LLC
LAMOTRIGINE LAMOTRIGINE 2MG TABLET, CHEWABLE;ORAL Prescription No AB 076928 WATSON LABS

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