Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076420
Company: TEVA
Company: TEVA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LAMOTRIGINE | LAMOTRIGINE | 5MG | TABLET, FOR SUSPENSION;ORAL | Discontinued | None | No | No |
| LAMOTRIGINE | LAMOTRIGINE | 25MG | TABLET, FOR SUSPENSION;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 |
|---|---|---|---|---|---|---|---|
| 06/21/2006 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/076420s000LTR.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 09/20/2016 | SUPPL-18 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 09/20/2016 | SUPPL-17 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 09/20/2016 | SUPPL-16 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/26/2014 | SUPPL-15 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 09/26/2014 | SUPPL-14 | 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. |
||
| 04/28/2012 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/28/2012 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/28/2012 | SUPPL-9 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 11/02/2010 | SUPPL-8 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 04/28/2010 | SUPPL-7 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 07/28/2010 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/31/2007 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 03/12/2007 | SUPPL-1 | Labeling |
Label is not available on this site. |