Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075451
Company: MYLAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LOVASTATIN LOVASTATIN 10MG TABLET;ORAL Discontinued None No No
LOVASTATIN LOVASTATIN 20MG TABLET;ORAL Discontinued None No No
LOVASTATIN LOVASTATIN 40MG 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
12/17/2001 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
08/04/2017 SUPPL-24 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

11/02/2014 SUPPL-23 Labeling-Package Insert

Label is not available on this site.

01/29/2013 SUPPL-20 Labeling-Package Insert

Label is not available on this site.

05/29/2012 SUPPL-19 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

09/03/2014 SUPPL-14 Labeling

Label is not available on this site.

02/12/2007 SUPPL-9 Labeling

Label is not available on this site.

04/20/2005 SUPPL-5 Labeling

Label is not available on this site.

10/11/2002 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

07/11/2002 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

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