Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076388
Company: TEVA
Company: TEVA
| 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 |
|---|---|---|---|---|---|---|---|
| 08/30/2006 | ORIG-1 | Approval |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/076388s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2006/076388Orig1s000Approv.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 09/30/2016 | SUPPL-28 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/30/2016 | SUPPL-27 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 09/30/2016 | SUPPL-26 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/26/2014 | SUPPL-24 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/26/2014 | SUPPL-23 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/26/2014 | SUPPL-21 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/30/2012 | SUPPL-20 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/30/2012 | SUPPL-19 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 09/29/2011 | SUPPL-17 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 04/28/2010 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/28/2010 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/20/2009 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 03/14/2008 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 10/31/2007 | SUPPL-1 | Labeling |
Label is not available on this site. |