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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. It is available from one supplier. 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. Nineteen suppliers are listed for this compound. Additional details are available on the cilostazol profile page.

Summary for NDA: 020863

Tradename:
PLETAL
Applicant:
Otsuka
Ingredient:
cilostazol
Patents:0
Therapeutic Class:Blood Products/Modifiers/ Volume Expanders
Formulation / Manufacturing:see details

Pharmacology for NDA: 020863

Suppliers and Packaging for NDA: 020863

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PLETAL
cilostazol
TABLET;ORAL 020863 NDA Otsuka America Pharmaceutical, Inc. 59148-003 59148-003-16 60 TABLET in 1 BOTTLE, PLASTIC (59148-003-16)

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength50MG
Approval Date:Jan 15, 1999TE:RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength100MG
Approval Date:Jan 15, 1999TE:RLD:No

Expired Orange Book Patents for NDA: 020863

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Otsuka
PLETAL
cilostazol
TABLET;ORAL020863-001Jan 15, 19994,277,479► subscribe
Otsuka
PLETAL
cilostazol
TABLET;ORAL020863-002Jan 15, 19994,277,479► subscribe
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