Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020863
Company: OTSUKA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PLETAL CILOSTAZOL 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
PLETAL CILOSTAZOL 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No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
01/15/1999 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Label
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/cilo_label.htm https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/cilostazol_letter.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20863.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/17/2017 SUPPL-24 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020863s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020863Orig1s024ltr.pdf
07/30/2015 SUPPL-23 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020863s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020863Orig1s023ltr.pdf
01/23/2015 SUPPL-22 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020863s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020863Orig1s022ltr.pdf
11/13/2007 SUPPL-21 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020863s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020863s021ltr.pdf
01/18/2007 SUPPL-19 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020863s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020863s019ltr.pdf
11/23/2005 SUPPL-11 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020863s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020863s011ltr.pdf
09/20/2002 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

02/04/2004 SUPPL-7 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20863slr007ltr.pdf
03/07/2001 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

12/27/2000 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

07/07/2000 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

06/26/2000 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

02/16/2000 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

03/31/1999 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
05/17/2017 SUPPL-24 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020863s024lbl.pdf
07/30/2015 SUPPL-23 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020863s023lbl.pdf
01/23/2015 SUPPL-22 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020863s022lbl.pdf
11/13/2007 SUPPL-21 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020863s021lbl.pdf
01/18/2007 SUPPL-19 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020863s019lbl.pdf
11/23/2005 SUPPL-11 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020863s011lbl.pdf
01/15/1999 ORIG-1 Approval https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/cilo_label.htm

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