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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077323
Company: RISING
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CILOSTAZOL CILOSTAZOL 100MG TABLET;ORAL Discontinued None No No
CILOSTAZOL CILOSTAZOL 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
04/20/2006 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
12/28/2017 SUPPL-8 Labeling-Patient Package Insert, Labeling-Package Insert

Label is not available on this site.

12/28/2017 SUPPL-7 Labeling-Package Insert

Label is not available on this site.

05/10/2011 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

08/31/2010 SUPPL-5 Labeling

Label is not available on this site.

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