Product Details for NDA 020863
PLETAL (CILOSTAZOL)
50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: CILOSTAZOL
Proprietary Name: PLETAL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N020863
Product Number: 001
Approval Date: Jan 15, 1999
Applicant Holder Full Name: OTSUKA PHARMACEUTICAL CO LTD
Marketing Status: Discontinued
Patent and Exclusivity Information
PLETAL (CILOSTAZOL)
Proprietary Name: PLETAL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N020863
Product Number: 001
Approval Date: Jan 15, 1999
Applicant Holder Full Name: OTSUKA PHARMACEUTICAL CO LTD
Marketing Status: Discontinued
Patent and Exclusivity Information
100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: CILOSTAZOL
Proprietary Name: PLETAL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N020863
Product Number: 002
Approval Date: Jan 15, 1999
Applicant Holder Full Name: OTSUKA PHARMACEUTICAL CO LTD
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: PLETAL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N020863
Product Number: 002
Approval Date: Jan 15, 1999
Applicant Holder Full Name: OTSUKA PHARMACEUTICAL CO LTD
Marketing Status: Discontinued
Patent and Exclusivity Information