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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 204589

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NDA 204589 describes EPTIFIBATIDE, which is a drug marketed by Accord Hlthcare, Amneal Pharms, Baxter Hlthcare Corp, Eugia Pharma, Hong Kong, Hybio, Mylan Labs Ltd, Rising, Sagent Pharms Inc, Shuangcheng, Slate Run Pharma, Teva Pharms Usa, and USV, and is included in fifteen NDAs. It is available from nine suppliers. Additional details are available on the EPTIFIBATIDE profile page.

The generic ingredient in EPTIFIBATIDE is eptifibatide. There are fifteen drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the eptifibatide profile page.

Summary for 204589

Tradename:	EPTIFIBATIDE
Applicant:	Rising
Ingredient:	eptifibatide
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	2MG/ML
Approval Date:	Apr 18, 2017	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	75MG/100ML
Approval Date:	Apr 18, 2017	TE:		RLD:	No

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