Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 077860
Company: WATSON LABS
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
12/05/2008 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
02/13/2012 SUPPL-2 Labeling-Medication Guide, Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

04/22/2011 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

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