Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 077633
Company: ZYDUS PHARMS USA
Company: ZYDUS PHARMS USA
| 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 | 50MG | TABLET;ORAL | Prescription | None | 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 |
| LAMOTRIGINE | LAMOTRIGINE | 250MG | TABLET;ORAL | Prescription | None | 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 |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/2009/077633Orig1s000Approv.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 06/10/2022 | SUPPL-37 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 06/10/2022 | SUPPL-35 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 10/29/2019 | SUPPL-32 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/29/2019 | SUPPL-31 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/29/2019 | SUPPL-30 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 10/29/2019 | SUPPL-29 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/29/2019 | SUPPL-28 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 12/11/2015 | SUPPL-24 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/11/2015 | SUPPL-20 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/11/2015 | SUPPL-18 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 12/11/2015 | SUPPL-17 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 09/26/2014 | SUPPL-16 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/26/2014 | SUPPL-12 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 09/26/2014 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/27/2012 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/27/2012 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/28/2012 | SUPPL-6 | REMS-Modified |
Label is not available on this site. |
||
| 09/29/2011 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/25/2011 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/23/2010 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/23/2010 | SUPPL-1 | Labeling-Medication Guide, REMS-Proposal |
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 | 079132 | JUBILANT CADISTA |
| LAMOTRIGINE | LAMOTRIGINE | 25MG | TABLET;ORAL | Prescription | No | AB | 078691 | LUPIN LTD |
| LAMOTRIGINE | LAMOTRIGINE | 25MG | TABLET;ORAL | Prescription | No | AB | 078625 | RUBICON |
| 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 | 079132 | JUBILANT CADISTA |
| LAMOTRIGINE | LAMOTRIGINE | 100MG | TABLET;ORAL | Prescription | No | AB | 078691 | LUPIN LTD |
| LAMOTRIGINE | LAMOTRIGINE | 100MG | TABLET;ORAL | Prescription | No | AB | 078625 | RUBICON |
| 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 | 079132 | JUBILANT CADISTA |
| LAMOTRIGINE | LAMOTRIGINE | 150MG | TABLET;ORAL | Prescription | No | AB | 078691 | LUPIN LTD |
| LAMOTRIGINE | LAMOTRIGINE | 150MG | TABLET;ORAL | Prescription | No | AB | 078625 | RUBICON |
| 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 | 079132 | JUBILANT CADISTA |
| LAMOTRIGINE | LAMOTRIGINE | 200MG | TABLET;ORAL | Prescription | No | AB | 078691 | LUPIN LTD |
| LAMOTRIGINE | LAMOTRIGINE | 200MG | TABLET;ORAL | Prescription | No | AB | 078625 | RUBICON |
| 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 |