Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 078828
Company: JUBILANT CADISTA
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
03/23/2009 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
06/30/2011 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

03/16/2011 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

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