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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077914
Company: ACTAVIS TOTOWA TEVA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FINASTERIDE FINASTERIDE 5MG 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
03/28/2007 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
12/15/2014 SUPPL-9 Labeling-Package Insert

Label is not available on this site.

04/29/2013 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

07/20/2012 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

02/13/2012 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

12/22/2010 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

01/27/2011 SUPPL-1 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

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