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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076288
Company: MYLAN
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
09/15/2008 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
10/01/2021 SUPPL-20 Labeling-Package Insert

Label is not available on this site.

11/03/2020 SUPPL-19 Labeling-Package Insert

Label is not available on this site.

11/03/2020 SUPPL-18 Labeling-Package Insert

Label is not available on this site.

11/03/2020 SUPPL-17 Labeling-Package Insert

Label is not available on this site.

11/03/2020 SUPPL-14 Labeling-Package Insert

Label is not available on this site.

11/03/2020 SUPPL-13 Labeling-Package Insert

Label is not available on this site.

01/05/2016 SUPPL-11 Labeling-Package Insert

Label is not available on this site.

03/21/2013 SUPPL-10 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

02/13/2012 SUPPL-7 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

04/22/2011 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

12/29/2010 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

04/27/2010 SUPPL-2 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

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