Details for New Drug Application (NDA): 203258

NDA 203258 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 203258

Tradename:	EPTIFIBATIDE
Applicant:	Mylan Labs Ltd
Ingredient:	eptifibatide
Patents:	0

Pharmacology for NDA: 203258

Physiological Effect

Decreased Platelet Aggregation

Suppliers and Packaging for NDA: 203258

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
EPTIFIBATIDE	eptifibatide	INJECTABLE;INJECTION	203258	ANDA	Mylan Institutional LLC	67457-629	67457-629-10	1 VIAL in 1 CARTON (67457-629-10) / 10 mL in 1 VIAL
EPTIFIBATIDE	eptifibatide	INJECTABLE;INJECTION	203258	ANDA	Mylan Institutional LLC	67457-630	67457-630-10	1 VIAL in 1 CARTON (67457-630-10) / 100 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	2MG/ML
Approval Date:	Jul 20, 2018	TE:	AP	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	75MG/100ML
Approval Date:	Jul 20, 2018	TE:	AP	RLD:	No

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