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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020863
Company: OTSUKA

Products on NDA 020863

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PLETAL	CILOSTAZOL	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No
PLETAL	CILOSTAZOL	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020863

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.

Labels for NDA 020863

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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