Last Updated: November 8, 2026

Details for New Drug Application (NDA): 204362

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NDA 204362 describes EPTIFIBATIDE, which is a drug marketed by Accord Hlthcare, Amneal Pharms, Baxter Hlthcare Corp, Eugia Pharma, Hainan Poly, Hybio, Meitheal, Mylan Labs Ltd, Quagen, Rising, Sagent Pharms Inc, 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 is one drug master file entry for this compound. Eight suppliers are listed for this compound. Additional details are available on the eptifibatide profile page.

Summary for 204362

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

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	2MG/ML
Approval Date:	Mar 11, 2019	TE:		RLD:	No

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