Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 022251
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
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
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 200828 IMPAX LABS INC
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 200828 IMPAX LABS INC
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 200828 IMPAX LABS INC
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 200828 IMPAX LABS INC
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

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English