Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 076052
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
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.

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.

09/24/2009 SUPPL-17 Labeling

Label is not available on this site.

08/18/2009 SUPPL-14 Labeling

Label is not available on this site.

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.

12/20/2006 SUPPL-4 Manufacturing (CMC)-New Strength

Label is not available on this site.

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