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. Nine 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

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Jan 15, 1999	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Jan 15, 1999	TE:		RLD:	Yes

Expired US Patents for NDA 020863

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Otsuka	PLETAL	cilostazol	TABLET;ORAL	020863-001	Jan 15, 1999	⤷ Sign Up	⤷ Sign Up
Otsuka	PLETAL	cilostazol	TABLET;ORAL	020863-002	Jan 15, 1999	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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