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Last Updated: December 27, 2024

Details for New Drug Application (NDA): 077831

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NDA 077831 describes CILOSTAZOL, which is a drug marketed by Actavis Elizabeth, Apotex Inc, Aurobindo Pharma Usa, Chartwell Rx, Epic Pharma Llc, Hikma, Ivax Sub Teva Pharms, Nostrum Labs Inc, Pliva Hrvatska Doo, Rising, 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 077831

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

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	100MG
Approval Date:	Sep 24, 2012	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	50MG
Approval Date:	Sep 24, 2012	TE:	AB	RLD:	No

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