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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 205557

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NDA 205557 describes EPTIFIBATIDE, which is a drug marketed by Accord Hlthcare, Amneal Pharms, Baxter Hlthcare Corp, Eugia Pharma, Hybio, Meitheal, 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 eight 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. Eight suppliers are listed for this compound. Additional details are available on the eptifibatide profile page.

Summary for 205557

Tradename:	EPTIFIBATIDE
Applicant:	Accord Hlthcare
Ingredient:	eptifibatide
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	2MG/ML
Approval Date:	Nov 6, 2017	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	75MG/100ML
Approval Date:	Nov 6, 2017	TE:		RLD:	No

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