Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 077420
Company: RISING
Company: RISING
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LAMOTRIGINE | LAMOTRIGINE | 25MG | TABLET;ORAL | Discontinued | None | No | No |
LAMOTRIGINE | LAMOTRIGINE | 100MG | TABLET;ORAL | Discontinued | None | No | No |
LAMOTRIGINE | LAMOTRIGINE | 150MG | TABLET;ORAL | Discontinued | None | No | No |
LAMOTRIGINE | LAMOTRIGINE | 200MG | TABLET;ORAL | Discontinued | 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 |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
11/20/2019 | SUPPL-18 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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11/20/2019 | SUPPL-17 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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04/13/2017 | SUPPL-16 | Labeling-Package Insert |
Label is not available on this site. |
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04/13/2017 | SUPPL-15 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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04/13/2017 | SUPPL-13 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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04/13/2017 | SUPPL-12 | Labeling-Container/Carton Labels |
Label is not available on this site. |
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03/16/2012 | SUPPL-11 | Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert, REMS-Modified |
Label is not available on this site. |
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01/10/2011 | SUPPL-8 | Labeling-Medication Guide, Labeling-Package Insert, REMS-Modified |
Label is not available on this site. |
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10/30/2010 | SUPPL-5 | Labeling-Container/Carton Labels, REMS-Modified |
Label is not available on this site. |
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11/25/2009 | SUPPL-1 | Labeling-Container/Carton Labels, Labeling-Medication Guide, REMS-Proposal |
Label is not available on this site. |