Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020863
Company: OTSUKA
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PLETAL | CILOSTAZOL | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
PLETAL | CILOSTAZOL | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
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 |