Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078947
Company: TORRENT PHARMS
Company: TORRENT PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LAMOTRIGINE | LAMOTRIGINE | 25MG | TABLET;ORAL | Prescription | AB | No | No |
| LAMOTRIGINE | LAMOTRIGINE | 100MG | TABLET;ORAL | Prescription | AB | No | No |
| LAMOTRIGINE | LAMOTRIGINE | 150MG | TABLET;ORAL | Prescription | AB | No | No |
| LAMOTRIGINE | LAMOTRIGINE | 200MG | TABLET;ORAL | Prescription | AB | No | 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 |
|---|---|---|---|---|---|---|---|
| 01/27/2009 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/10/2026 | SUPPL-43 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 04/10/2026 | SUPPL-42 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 04/10/2026 | SUPPL-41 | Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 04/10/2026 | SUPPL-40 | Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 06/30/2022 | SUPPL-38 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 06/30/2022 | SUPPL-37 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 12/06/2019 | SUPPL-34 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 12/06/2019 | SUPPL-33 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 12/06/2019 | SUPPL-32 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 01/29/2018 | SUPPL-26 | Labeling-Package Insert, Labeling-Proprietary Name Change |
Label is not available on this site. |
||
| 06/16/2017 | SUPPL-23 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/16/2017 | SUPPL-22 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/10/2014 | SUPPL-21 | Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 12/10/2014 | SUPPL-18 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/14/2012 | SUPPL-15 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/31/2012 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/29/2011 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/28/2010 | SUPPL-9 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 01/21/2010 | SUPPL-8 | REMS-Modified |
Label is not available on this site. |
||
| 09/21/2009 | SUPPL-6 | Labeling, REMS-Proposal |
Label is not available on this site. |
||
| 09/21/2009 | SUPPL-5 | Labeling |
Label is not available on this site. |
LAMOTRIGINE
TABLET;ORAL; 25MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| LAMICTAL | LAMOTRIGINE | 25MG | TABLET;ORAL | Prescription | Yes | AB | 020241 | GLAXOSMITHKLINE LLC |
| LAMOTRIGINE | LAMOTRIGINE | 25MG | TABLET;ORAL | Prescription | No | AB | 090607 | ALEMBIC PHARMS LTD |
| LAMOTRIGINE | LAMOTRIGINE | 25MG | TABLET;ORAL | Prescription | No | AB | 200694 | ALKEM LABS LTD |
| LAMOTRIGINE | LAMOTRIGINE | 25MG | TABLET;ORAL | Prescription | No | AB | 078956 | AUROBINDO PHARMA |
| LAMOTRIGINE | LAMOTRIGINE | 25MG | TABLET;ORAL | Prescription | No | AB | 076708 | DR REDDYS LABS LTD |
| LAMOTRIGINE | LAMOTRIGINE | 25MG | TABLET;ORAL | Prescription | No | AB | 090169 | GLENMARK PHARMS LTD |
| LAMOTRIGINE | LAMOTRIGINE | 25MG | TABLET;ORAL | Prescription | No | AB | 204499 | IPCA LABS |
| LAMOTRIGINE | LAMOTRIGINE | 25MG | TABLET;ORAL | Prescription | No | AB | 079132 | JUBILANT CADISTA |
| LAMOTRIGINE | LAMOTRIGINE | 25MG | TABLET;ORAL | Prescription | No | AB | 078625 | RUBICON RESEARCH |
| LAMOTRIGINE | LAMOTRIGINE | 25MG | TABLET;ORAL | Prescription | No | AB | 078525 | TARO PHARM INDS |
| LAMOTRIGINE | LAMOTRIGINE | 25MG | TABLET;ORAL | Prescription | No | AB | 078947 | TORRENT PHARMS |
| LAMOTRIGINE | LAMOTRIGINE | 25MG | TABLET;ORAL | Prescription | No | AB | 090170 | UNICHEM LABS LTD |
| LAMOTRIGINE | LAMOTRIGINE | 25MG | TABLET;ORAL | Prescription | No | AB | 077633 | ZYDUS PHARMS USA |
TABLET;ORAL; 100MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| LAMICTAL | LAMOTRIGINE | 100MG | TABLET;ORAL | Prescription | Yes | AB | 020241 | GLAXOSMITHKLINE LLC |
| LAMOTRIGINE | LAMOTRIGINE | 100MG | TABLET;ORAL | Prescription | No | AB | 090607 | ALEMBIC PHARMS LTD |
| LAMOTRIGINE | LAMOTRIGINE | 100MG | TABLET;ORAL | Prescription | No | AB | 200694 | ALKEM LABS LTD |
| LAMOTRIGINE | LAMOTRIGINE | 100MG | TABLET;ORAL | Prescription | No | AB | 078956 | AUROBINDO PHARMA |
| LAMOTRIGINE | LAMOTRIGINE | 100MG | TABLET;ORAL | Prescription | No | AB | 076708 | DR REDDYS LABS LTD |
| LAMOTRIGINE | LAMOTRIGINE | 100MG | TABLET;ORAL | Prescription | No | AB | 090169 | GLENMARK PHARMS LTD |
| LAMOTRIGINE | LAMOTRIGINE | 100MG | TABLET;ORAL | Prescription | No | AB | 204499 | IPCA LABS |
| LAMOTRIGINE | LAMOTRIGINE | 100MG | TABLET;ORAL | Prescription | No | AB | 079132 | JUBILANT CADISTA |
| LAMOTRIGINE | LAMOTRIGINE | 100MG | TABLET;ORAL | Prescription | No | AB | 078625 | RUBICON RESEARCH |
| LAMOTRIGINE | LAMOTRIGINE | 100MG | TABLET;ORAL | Prescription | No | AB | 078525 | TARO PHARM INDS |
| LAMOTRIGINE | LAMOTRIGINE | 100MG | TABLET;ORAL | Prescription | No | AB | 078947 | TORRENT PHARMS |
| LAMOTRIGINE | LAMOTRIGINE | 100MG | TABLET;ORAL | Prescription | No | AB | 090170 | UNICHEM LABS LTD |
| LAMOTRIGINE | LAMOTRIGINE | 100MG | TABLET;ORAL | Prescription | No | AB | 077633 | ZYDUS PHARMS USA |
TABLET;ORAL; 150MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| LAMICTAL | LAMOTRIGINE | 150MG | TABLET;ORAL | Prescription | Yes | AB | 020241 | GLAXOSMITHKLINE LLC |
| LAMOTRIGINE | LAMOTRIGINE | 150MG | TABLET;ORAL | Prescription | No | AB | 090607 | ALEMBIC PHARMS LTD |
| LAMOTRIGINE | LAMOTRIGINE | 150MG | TABLET;ORAL | Prescription | No | AB | 200694 | ALKEM LABS LTD |
| LAMOTRIGINE | LAMOTRIGINE | 150MG | TABLET;ORAL | Prescription | No | AB | 078956 | AUROBINDO PHARMA |
| LAMOTRIGINE | LAMOTRIGINE | 150MG | TABLET;ORAL | Prescription | No | AB | 076708 | DR REDDYS LABS LTD |
| LAMOTRIGINE | LAMOTRIGINE | 150MG | TABLET;ORAL | Prescription | No | AB | 090169 | GLENMARK PHARMS LTD |
| LAMOTRIGINE | LAMOTRIGINE | 150MG | TABLET;ORAL | Prescription | No | AB | 204499 | IPCA LABS |
| LAMOTRIGINE | LAMOTRIGINE | 150MG | TABLET;ORAL | Prescription | No | AB | 079132 | JUBILANT CADISTA |
| LAMOTRIGINE | LAMOTRIGINE | 150MG | TABLET;ORAL | Prescription | No | AB | 078625 | RUBICON RESEARCH |
| LAMOTRIGINE | LAMOTRIGINE | 150MG | TABLET;ORAL | Prescription | No | AB | 078525 | TARO PHARM INDS |
| LAMOTRIGINE | LAMOTRIGINE | 150MG | TABLET;ORAL | Prescription | No | AB | 078947 | TORRENT PHARMS |
| LAMOTRIGINE | LAMOTRIGINE | 150MG | TABLET;ORAL | Prescription | No | AB | 090170 | UNICHEM LABS LTD |
| LAMOTRIGINE | LAMOTRIGINE | 150MG | TABLET;ORAL | Prescription | No | AB | 077633 | ZYDUS PHARMS USA |
TABLET;ORAL; 200MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| LAMICTAL | LAMOTRIGINE | 200MG | TABLET;ORAL | Prescription | Yes | AB | 020241 | GLAXOSMITHKLINE LLC |
| LAMOTRIGINE | LAMOTRIGINE | 200MG | TABLET;ORAL | Prescription | No | AB | 090607 | ALEMBIC PHARMS LTD |
| LAMOTRIGINE | LAMOTRIGINE | 200MG | TABLET;ORAL | Prescription | No | AB | 200694 | ALKEM LABS LTD |
| LAMOTRIGINE | LAMOTRIGINE | 200MG | TABLET;ORAL | Prescription | No | AB | 078956 | AUROBINDO PHARMA |
| LAMOTRIGINE | LAMOTRIGINE | 200MG | TABLET;ORAL | Prescription | No | AB | 076708 | DR REDDYS LABS LTD |
| LAMOTRIGINE | LAMOTRIGINE | 200MG | TABLET;ORAL | Prescription | No | AB | 090169 | GLENMARK PHARMS LTD |
| LAMOTRIGINE | LAMOTRIGINE | 200MG | TABLET;ORAL | Prescription | No | AB | 204499 | IPCA LABS |
| LAMOTRIGINE | LAMOTRIGINE | 200MG | TABLET;ORAL | Prescription | No | AB | 079132 | JUBILANT CADISTA |
| LAMOTRIGINE | LAMOTRIGINE | 200MG | TABLET;ORAL | Prescription | No | AB | 078625 | RUBICON RESEARCH |
| LAMOTRIGINE | LAMOTRIGINE | 200MG | TABLET;ORAL | Prescription | No | AB | 078525 | TARO PHARM INDS |
| LAMOTRIGINE | LAMOTRIGINE | 200MG | TABLET;ORAL | Prescription | No | AB | 078947 | TORRENT PHARMS |
| LAMOTRIGINE | LAMOTRIGINE | 200MG | TABLET;ORAL | Prescription | No | AB | 090170 | UNICHEM LABS LTD |
| LAMOTRIGINE | LAMOTRIGINE | 200MG | TABLET;ORAL | Prescription | No | AB | 077633 | ZYDUS PHARMS USA |