Details for New Drug Application (NDA): 213599

NDA 213599 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 213599

Tradename:	EPTIFIBATIDE
Applicant:	Hong Kong
Ingredient:	eptifibatide
Patents:	0

Pharmacology for NDA: 213599

Physiological Effect

Decreased Platelet Aggregation

Suppliers and Packaging for NDA: 213599

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
EPTIFIBATIDE	eptifibatide	INJECTABLE;INJECTION	213599	ANDA	Meitheal Pharmaceuticals Inc.	71288-412	71288-412-10	1 VIAL, SINGLE-DOSE in 1 CARTON (71288-412-10) / 10 mL in 1 VIAL, SINGLE-DOSE
EPTIFIBATIDE	eptifibatide	INJECTABLE;INJECTION	213599	ANDA	Meitheal Pharmaceuticals Inc.	71288-413	71288-413-51	1 VIAL, SINGLE-DOSE in 1 CARTON (71288-413-51) / 100 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	2MG/ML
Approval Date:	May 9, 2024	TE:	AP	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	75MG/100ML
Approval Date:	May 9, 2024	TE:	AP	RLD:	No

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