Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076052
Company: IVAX SUB TEVA PHARMS
Company: IVAX SUB TEVA PHARMS
| 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 |
|---|---|---|---|---|---|---|---|
| 06/23/2006 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/076052s000LTR.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 07/31/2023 | SUPPL-48 | Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 07/31/2023 | SUPPL-44 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/16/2015 | SUPPL-40 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/05/2014 | SUPPL-39 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/05/2014 | SUPPL-38 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/18/2012 | SUPPL-37 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/23/2012 | SUPPL-34 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/22/2011 | SUPPL-32 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/26/2011 | SUPPL-31 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/16/2011 | SUPPL-29 | Labeling-Package Insert |
Label is not available on this site. |
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| 09/17/2010 | SUPPL-26 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/17/2010 | SUPPL-23 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/12/2010 | SUPPL-21 | Labeling |
Label is not available on this site. |
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| 09/24/2009 | SUPPL-17 | Labeling |
Label is not available on this site. |
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| 08/18/2009 | SUPPL-14 | Labeling |
Label is not available on this site. |
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| 04/25/2008 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 12/20/2006 | SUPPL-5 | Labeling |
Label is not available on this site. |
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| 12/20/2006 | SUPPL-4 | Manufacturing (CMC)-New Strength |
Label is not available on this site. |