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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 077310

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NDA 077310 describes CILOSTAZOL, which is a drug marketed by Actavis Elizabeth, Apotex, Aurobindo Pharma Usa, Chartwell Rx, Epic Pharma Llc, Hikma, Ivax Sub Teva Pharms, Pliva Hrvatska Doo, Rising, Sankalp Lifecare, Slate Run Pharma, and Teva, and is included in fourteen NDAs. It is available from nine suppliers. Additional details are available on the CILOSTAZOL profile page.

The generic ingredient in CILOSTAZOL 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 077310

Tradename:	CILOSTAZOL
Applicant:	Chartwell Rx
Ingredient:	cilostazol
Patents:	0

Pharmacology for NDA: 077310

Mechanism of Action	Phosphodiesterase 3 Inhibitors

Suppliers and Packaging for NDA: 077310

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CILOSTAZOL	cilostazol	TABLET;ORAL	077310	ANDA	Chartwell RX, LLC	62135-983	62135-983-60	60 TABLET in 1 BOTTLE (62135-983-60)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	50MG
Approval Date:	Nov 8, 2005	TE:		RLD:	No

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