Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022115
Company: GLAXOSMITHKLINE LLC
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 |
|---|---|---|---|---|---|
| 03/31/2021 | SUPPL-29 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022115s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020241Orig1s064, 020764Orig1s057, 022251Orig1s028, 022115Orig1s029ltr.pdf | |
| 08/31/2020 | SUPPL-27 | 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 | |
| 09/25/2019 | SUPPL-26 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022115s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020241Orig1s060, 020764Orig1s053, 022251Orig1s024, 022115Orig1s026ltr.pdf | |
| 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 | |
| 10/09/2020 | SUPPL-24 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022115s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020241Orig1s058, 020764Orig1s051, 022251Orig1s022, 022115Orig1s024ltr.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 |
|---|---|---|---|---|---|
| 03/31/2021 | SUPPL-29 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022115s029lbl.pdf | |
| 10/09/2020 | SUPPL-24 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022115s024lbl.pdf | |
| 08/31/2020 | SUPPL-27 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020241s062,020764s055,022251s026,022115s027lbl.pdf | |
| 09/25/2019 | SUPPL-26 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022115s026lbl.pdf | |
| 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 | 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 BIO AG |
| LAMOTRIGINE | LAMOTRIGINE | 25MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 213949 | YILING |
| LAMOTRIGINE | LAMOTRIGINE | 25MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 207763 | ZYDUS PHARMS |
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 | 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 BIO AG |
| LAMOTRIGINE | LAMOTRIGINE | 50MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 213949 | YILING |
| LAMOTRIGINE | LAMOTRIGINE | 50MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 207763 | ZYDUS PHARMS |
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 | 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 BIO AG |
| LAMOTRIGINE | LAMOTRIGINE | 100MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 213949 | YILING |
| LAMOTRIGINE | LAMOTRIGINE | 100MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 207763 | ZYDUS PHARMS |
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 | 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 | 202498 | WOCKHARDT BIO AG |
| LAMOTRIGINE | LAMOTRIGINE | 200MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 213949 | YILING |
| LAMOTRIGINE | LAMOTRIGINE | 200MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 207763 | ZYDUS PHARMS |
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 | 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 BIO AG |
| LAMOTRIGINE | LAMOTRIGINE | 300MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 213949 | YILING |
| LAMOTRIGINE | LAMOTRIGINE | 300MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 207763 | ZYDUS PHARMS |
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 | 200672 | 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 | 202383 | DR REDDYS LABS LTD |
| LAMOTRIGINE | LAMOTRIGINE | 250MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 201791 | PAR PHARM |
| LAMOTRIGINE | LAMOTRIGINE | 250MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 213949 | YILING |
| LAMOTRIGINE | LAMOTRIGINE | 250MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 207763 | ZYDUS PHARMS |