Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076932
Company: TEVA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BICALUTAMIDE BICALUTAMIDE 50MG 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
07/06/2009 ORIG-1 Approval Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/076932s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/076932s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/19/2016 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

12/12/2013 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

05/08/2011 SUPPL-2 Labeling-Patient Package Insert, Labeling-Package Insert

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/06/2009 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/076932s000lbl.pdf

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