Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 079204
Company: TARO
Company: TARO
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LAMOTRIGINE | LAMOTRIGINE | 5MG | TABLET, FOR SUSPENSION;ORAL | Prescription | AB | No | No |
LAMOTRIGINE | LAMOTRIGINE | 25MG | TABLET, FOR SUSPENSION;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 |
---|---|---|---|---|---|---|---|
02/04/2009 | 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 |
---|---|---|---|---|---|
12/12/2014 | SUPPL-8 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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12/12/2014 | SUPPL-7 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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12/12/2014 | SUPPL-6 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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05/16/2012 | SUPPL-5 | Labeling-Medication Guide, Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
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03/15/2012 | SUPPL-4 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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09/29/2011 | SUPPL-2 | Labeling-Medication Guide, REMS-Proposal |
Label is not available on this site. |
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02/23/2010 | SUPPL-1 | Labeling-Package Insert, Labeling-Container/Carton Labels, Labeling-Medication Guide, REMS-Proposal |
Label is not available on this site. |
LAMOTRIGINE
TABLET, FOR SUSPENSION;ORAL; 5MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
LAMICTAL CD | LAMOTRIGINE | 5MG | TABLET, FOR SUSPENSION;ORAL | Prescription | Yes | AB | 020764 | GLAXOSMITHKLINE LLC |
LAMOTRIGINE | LAMOTRIGINE | 5MG | TABLET, FOR SUSPENSION;ORAL | Prescription | No | AB | 201168 | ALEMBIC |
LAMOTRIGINE | LAMOTRIGINE | 5MG | TABLET, FOR SUSPENSION;ORAL | Prescription | No | AB | 090401 | AUROBINDO PHARMA |
LAMOTRIGINE | LAMOTRIGINE | 5MG | TABLET, FOR SUSPENSION;ORAL | Prescription | No | AB | 076701 | DR REDDYS LABS LTD |
LAMOTRIGINE | LAMOTRIGINE | 5MG | TABLET, FOR SUSPENSION;ORAL | Prescription | No | AB | 079099 | GLENMARK PHARMS LTD |
LAMOTRIGINE | LAMOTRIGINE | 5MG | TABLET, FOR SUSPENSION;ORAL | Prescription | No | AB | 079204 | TARO |
LAMOTRIGINE | LAMOTRIGINE | 5MG | TABLET, FOR SUSPENSION;ORAL | Prescription | No | AB | 076928 | WATSON LABS |
LAMOTRIGINE | LAMOTRIGINE | 5MG | TABLET, FOR SUSPENSION;ORAL | Prescription | No | AB | 078009 | ZYDUS PHARMS USA INC |
TABLET, FOR SUSPENSION;ORAL; 25MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
LAMICTAL CD | LAMOTRIGINE | 25MG | TABLET, FOR SUSPENSION;ORAL | Prescription | Yes | AB | 020764 | GLAXOSMITHKLINE LLC |
LAMOTRIGINE | LAMOTRIGINE | 25MG | TABLET, FOR SUSPENSION;ORAL | Prescription | No | AB | 201168 | ALEMBIC |
LAMOTRIGINE | LAMOTRIGINE | 25MG | TABLET, FOR SUSPENSION;ORAL | Prescription | No | AB | 090401 | AUROBINDO PHARMA |
LAMOTRIGINE | LAMOTRIGINE | 25MG | TABLET, FOR SUSPENSION;ORAL | Prescription | No | AB | 076701 | DR REDDYS LABS LTD |
LAMOTRIGINE | LAMOTRIGINE | 25MG | TABLET, FOR SUSPENSION;ORAL | Prescription | No | AB | 079099 | GLENMARK PHARMS LTD |
LAMOTRIGINE | LAMOTRIGINE | 25MG | TABLET, FOR SUSPENSION;ORAL | Prescription | No | AB | 079204 | TARO |
LAMOTRIGINE | LAMOTRIGINE | 25MG | TABLET, FOR SUSPENSION;ORAL | Prescription | No | AB | 076928 | WATSON LABS |
LAMOTRIGINE | LAMOTRIGINE | 25MG | TABLET, FOR SUSPENSION;ORAL | Prescription | No | AB | 078009 | ZYDUS PHARMS USA INC |