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Last Updated: March 19, 2024

Details for New Drug Application (NDA): 020863


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NDA 020863 describes PLETAL, which is a drug marketed by Otsuka and is included in one NDA. Additional details are available on the PLETAL profile page.

The generic ingredient in PLETAL is cilostazol. There are twelve drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the cilostazol profile page.
Summary for 020863
Tradename:PLETAL
Applicant:Otsuka
Ingredient:cilostazol
Patents:0
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Jan 15, 1999TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Jan 15, 1999TE:RLD:Yes

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