Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 077084
Company: TEVA PHARMS
Company: TEVA PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LEFLUNOMIDE | LEFLUNOMIDE | 10MG | TABLET;ORAL | Discontinued | None | No | No |
| LEFLUNOMIDE | LEFLUNOMIDE | 20MG | 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 |
|---|---|---|---|---|---|---|---|
| 09/13/2005 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/077084ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/30/2011 | SUPPL-13 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 11/30/2010 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/28/2009 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/23/2008 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 04/23/2008 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 07/09/2007 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 03/31/2006 | SUPPL-2 | Labeling |
Label is not available on this site. |