Last Updated: November 8, 2026

Details for New Drug Application (NDA): 077019

« Back to Dashboard

NDA 077019 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 ten suppliers. Additional details are available on the CILOSTAZOL profile page.

The generic ingredient in CILOSTAZOL is cilostazol. There is one drug master file entry for this compound. Ten suppliers are listed for this compound. Additional details are available on the cilostazol profile page.

Summary for 077019

Tradename:	CILOSTAZOL
Applicant:	Aurobindo Pharma Usa
Ingredient:	cilostazol
Patents:	0

Pharmacology for NDA: 077019

Mechanism of Action	Phosphodiesterase 3 Inhibitors

Suppliers and Packaging for NDA: 077019

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CILOSTAZOL	cilostazol	TABLET;ORAL	077019	ANDA	Aurobindo Pharma Limited	84386-002	84386-002-60	60 TABLET in 1 BOTTLE (84386-002-60)
CILOSTAZOL	cilostazol	TABLET;ORAL	077019	ANDA	Aurobindo Pharma Limited	84386-003	84386-003-60	60 TABLET in 1 BOTTLE (84386-003-60)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	50MG
Approval Date:	Nov 23, 2004	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	100MG
Approval Date:	Nov 23, 2004	TE:	AB	RLD:	No

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.