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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 208554

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NDA 208554 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 208554

Tradename:	EPTIFIBATIDE
Applicant:	Baxter Hlthcare Corp
Ingredient:	eptifibatide
Patents:	0

Pharmacology for NDA: 208554

Physiological Effect	Decreased Platelet Aggregation

Suppliers and Packaging for NDA: 208554

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
EPTIFIBATIDE	eptifibatide	INJECTABLE;INJECTION	208554	ANDA	Baxter Healthcare Company	0338-9558	0338-9558-10	1 VIAL, SINGLE-DOSE in 1 CARTON (0338-9558-10) / 100 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	2MG/ML
Approval Date:	Nov 23, 2018	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	75MG/100ML
Approval Date:	Nov 23, 2018	TE:	AP	RLD:	No

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