Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076685
Company: WATSON LABS TEVA
Company: WATSON LABS TEVA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| SIMVASTATIN | SIMVASTATIN | 5MG | TABLET;ORAL | Discontinued | None | No | No |
| SIMVASTATIN | SIMVASTATIN | 10MG | TABLET;ORAL | Discontinued | None | No | No |
| SIMVASTATIN | SIMVASTATIN | 20MG | TABLET;ORAL | Discontinued | None | No | No |
| SIMVASTATIN | SIMVASTATIN | 40MG | TABLET;ORAL | Discontinued | None | No | No |
| SIMVASTATIN | SIMVASTATIN | 80MG | 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 |
|---|---|---|---|---|---|---|---|
| 12/20/2006 | 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 |
|---|---|---|---|---|---|
| 10/31/2008 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 06/18/2008 | SUPPL-7 | Labeling |
Label is not available on this site. |
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| 08/14/2007 | SUPPL-4 | Labeling |
Label is not available on this site. |