Drugs@FDA: FDA-Approved Drugs
Company: UNICHEM LABS LTD
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 |
---|---|---|---|---|---|---|---|
10/06/2011 | ORIG-1 | Approval |
Label (PDF)
Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/090170Orig1s000LBL.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2011/090170Orig1s000Approv.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
06/08/2023 | SUPPL-34 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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06/08/2023 | SUPPL-30 | Labeling-Package Insert |
Label is not available on this site. |
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06/08/2023 | SUPPL-29 | Labeling-Package Insert |
Label is not available on this site. |
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01/17/2020 | SUPPL-25 | Labeling-Package Insert |
Label is not available on this site. |
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01/17/2020 | SUPPL-23 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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01/17/2020 | SUPPL-21 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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01/17/2020 | SUPPL-15 | Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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12/10/2014 | SUPPL-9 | Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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12/10/2014 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
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05/21/2012 | SUPPL-2 | Labeling-Medication Guide, REMS-Modified |
Label is not available on this site. |
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03/27/2012 | SUPPL-1 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
10/06/2011 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/090170Orig1s000LBL.pdf |
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 |