Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 078740
Company: WEST WARD PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
RISPERIDONE RISPERIDONE 0.25MG TABLET;ORAL Discontinued None No No
RISPERIDONE RISPERIDONE 0.5MG TABLET;ORAL Discontinued None No No
RISPERIDONE RISPERIDONE 1MG TABLET;ORAL Discontinued None No No
RISPERIDONE RISPERIDONE 2MG TABLET;ORAL Discontinued None No No
RISPERIDONE RISPERIDONE 3MG TABLET;ORAL Discontinued None No No
RISPERIDONE RISPERIDONE 4MG 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
05/29/2009 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
12/31/2012 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

12/08/2011 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

03/15/2011 SUPPL-3 Labeling-Package Insert, Labeling-Package Insert

Label is not available on this site.

02/04/2010 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

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