Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076630
Company: MYLAN
Company: MYLAN
| 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 |
|---|---|---|---|---|---|---|---|
| 01/22/2009 | 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 |
|---|---|---|---|---|---|
| 03/19/2012 | SUPPL-5 | Labeling-Medication Guide, Labeling-Package Insert, Labeling-Container/Carton Labels, REMS-Modified |
Label is not available on this site. |
||
| 04/25/2011 | SUPPL-4 | Labeling-Container/Carton Labels, Labeling-Package Insert, REMS-Modified |
Label is not available on this site. |
||
| 04/27/2010 | SUPPL-1 | Labeling-Container/Carton Labels, REMS-Proposal |
Label is not available on this site. |